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  • Siemens Acuson X700 Brings Powerful Image Processing to Budget Friendly Ultrasound

    Siemens Acuson X700 Brings Powerful Image Processing to Budget Friendly Ultrasound

    Siemens Acuson X700 Brings Powerful Image Processing to Budget Friendly Ultrasound

    “A strong fourth quarter enabled us to fulfill our expectations for fiscal 2012 and achieve one of our best years ever. Even so, we didn’t fully succeed in significantly boosting our performance vis-à-vis competitors, as we did in recent years. To get back to reaching our own goals, we’ve launched “Siemens 2014,” a company-wide program aimed at raising our Total Sectors profit margin to at least 12 percent. We know what we have to do – and we’re doing it.”

    Peter Löscher, President and Chief Executive Officer of Siemens AG

    Financial Highlights:

    Revenue for the fourth quarter rose 7% year-over-year, to €21.703 billion, and orders rose 2% to €21.495 billion. On a comparable basis, excluding currency translation and portfolio effects, revenue was up 1% and orders declined 4%.

    Total Sectors profit was €2.119 billion, held back by substantial profit impacts in the Energy Sector.

    Income from continuing operations was €1.479 billion and corresponding basic EPS was €1.63.

    An outstanding fourth-quarter cash performance in the Sectors lifted Free cash flow from continuing operations to €4.343 billion, well above last year’s strong closing quarter.

    For fiscal 2012, revenue rose 7% year-over-year, to €78.296 billion, while orders came in 10% lower, at €76.913 billion, due to a significantly lower volume from large orders compared to the prior year. Total Sectors Profit was €7.543 billion and income from continuing operations was €5.184 billion. Siemens proposes a dividend of €3.00 per share, unchanged from fiscal 2011.

    Please read the complete Earnings Release in the attached PDF:

    Earnings Release

    All figures are preliminary and unaudited. This Earnings Release should be read in conjunction with information Siemens published today regarding legal proceedings.

    Financial Publications are available for download at: www.siemens.com/ir

    -> Publications & Events.

    This document includes supplemental financial measures that are or may be non-GAAP financial measures. New orders and order backlog; adjusted or organic growth rates of revenue and new orders; book-to-bill ratio; Total Sectors profit; return on equity (after tax), or ROE (after tax); return on capital employed (adjusted), or ROCE (adjusted); Free cash flow, or FCF; cash conversion rate, or CCR; adjusted EBITDA; adjusted EBIT; adjusted EBITDA margins, earnings effects from purchase price allocation, or PPA effects; net debt and adjusted industrial net debt are or may be such non-GAAP financial measures. These supplemental financial measures should not be viewed in isolation as alternatives to measures of Siemens’ financial condition, results of operations or cash flows as presented in accordance with IFRS in its Consolidated Financial Statements. Other companies that report or describe similarly titled financial measures may calculate them differently. Definitions of these supplemental financial measures, a discussion of the most directly comparable IFRS financial measures, information regarding the usefulness of Siemens’ supplemental financial measures, the limitations associated with these measures and reconciliations to the most comparable IFRS financial measures are available on Siemens’ Investor Relations website at www.siemens.com/nonGAAP. For additional information, see supplemental financial measures and the related discussion in Siemens’ most recent annual report on Form 20-F, which can be found on our Investor Relations website or via the EDGAR system on the website of the United States Securities and Exchange Commission.

    This document contains statements related to our future business and financial performance and future events or developments involving Siemens that may constitute forward-looking statements. These statements may be identified by words such as “expects,” “looks forward to,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “will,” “project” or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to stockholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Siemens’ management, and are, therefore, subject to certain risks and uncertainties. A variety of factors, many of which are beyond Siemens’ control, affect Siemens’ operations, performance, business strategy and results and could cause the actual results, performance or achievements of Siemens to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements or anticipated on the basis of historical trends. These factors include in particular, but are not limited to, the matters described in Item 3: Risk factors of our most recent annual report on Form 20-F filed with the SEC, in the chapter “Risks” of our most recent annual report prepared in accordance with the German Commercial Code, and in the chapter “Report on risks and opportunities” of our most recent interim report.

    Further information about risks and uncertainties affecting Siemens is included throughout our most recent annual, and interim reports as well as our most recent earnings release, which are available on the Siemens website, www.siemens.com, and throughout our most recent annual report on Form 20-F and in our other filings with the SEC, which are available on the Siemens website www.siemens.com, and on the SEC’s website, www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results, performance or achievements of Siemens may vary materially from those described in the relevant forward-looking statement as being expected, anticipated, intended, planned, believed, sought, estimated or projected. Siemens neither intends, nor assumes any obligation, to update or revise these forward-looking statements in light of developments which differ from those anticipated.

    Due to rounding, numbers presented throughout this and other documents may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures.

    Siemens is beefing up its budget conscious Acuson X line of ultrasounds with the new X700 device that features some of the technologies previously only available on the Acuson S series.

    The X700 optimizes ergonomics thanks to a 20 inch monitor mounted on a pivoting and rotating arm and the height adjustable control panel that helps clinicians of all sizes work easier whether sitting down or standing up. It features a couple USB ports on the front to quickly take recordings with you for later review.

    Acuson X700 2 Siemens Acuson X700 Brings Powerful Image Processing to Budget Friendly Ultrasound

    Some main features imported into the Acuson X700 according to Siemens:

    Advanced SieClear spatial compounding, for example, enhances anatomic border definition and improves tissue contrast through electronic beam steering, allowing rapid acquisition of overlapping images from different view angles. The Dynamic TCE (tissue contrast enhancement) technology also improves borders and reduces speckle/noise, facilitating subtle tissue differentiation. Moreover, the Acuson X700 system features intelligent workflow solutions to enable the high throughput required by various clinical departments that use the system. For example, the TGO (tissue grayscale optimization) technology provides instantaneous one-button image optimization by automatically adjusting the image brightness to the tissue type being imaged.

    Furthermore, Siemens has migrated its patented MicroPinless (MP) transducer connectors from premium platforms to the Acuson X700 system. MP connectors offer the highest signal fidelity and improve the signal-to-noise ratio to enhance signal quality. The transducers are compatible with Siemens’ Acuson S Family, Acuson X Family, and Acuson Sequoia ultrasound systems to increase flexibility and investment value for the customer. The Acuson X700 system also features a new, single-solution, 50-millimeter aperture linear array transducer for superficial as well as deep imaging. The proprietary Hanafy lens transducer technology provides continuous focusing and image uniformity while delivering superb contrast and detail resolution.

    The Acuson X700 system offers many features and options to accommodate a broad range of applications and clinical environments. For instance, 3-Scape real-time 3D imaging and Advanced fourSight technology support 3D/4D imaging for fetal, abdominal, and gynecological examinations. Multiple knowledge-based workflow applications support the workflow to ensure consistency. The software Syngo Auto OB Measurements, for example, draws on a large database of ultrasound images to provide instant automated biometric measurements of the fetus without manual calculations. Advanced cardiac imaging applications like intracardiac echocardiography imaging support physicians during procedure visualization and device placement monitoring. The system’s options and features can be configured individually to support various clinical needs.

    Source : http://www.siemens.com/press/en/pressrelease/?press=/en/pressrelease/2012/healthcare/clinical-products/hcp201211005.htm

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  • FAA Approves Variety of Oxygen Concentrators for Use on Airplanes

    FAA Approves Variety of Oxygen Concentrators for Use on Airplanes

    FAA Approves Variety of Oxygen Concentrators for Use on Airplanes

    Suresnes, France – Philips Respironics, a unit of Royal Philips Electronics (NYSE: PHG, AEX: PHI), announced that the United States Federal Aviation Administration (FAA) has approved the SimplyGo portable oxygen concentrator (POC) for in-flight use on commercial airliners.

    With the approval, SimplyGo becomes the only FAA-cleared portable oxygen concentrator (POC) that offers user-triggered and continuous flow in a design of fewer than 5 kg (10 pounds). SimplyGo has twice the oxygen output of any other POC at this weight and is able to meet the portable needs of nearly all oxygen users. FAA approval applies to all SimplyGo systems, including those in use prior to the announcement.

    The FAA rule approving the use of SimplyGo for in-flight use on U.S. carriers will become effective on or about October 31, 2012, which is 15 days after publication of the new rule in the Federal Register. To view the FAA statement, go to www.gpo.gov/fdsys/pkg/FR-2012-10-16/html/2012-25412.htm.

    “We are extremely pleased to inform oxygen users that they will be able to fly with the SimplyGo POC,” said Mats Dahlquist, Vice President Home Healthcare Solutions International. “Given its portability, oxygen output, and continuous flow capability, we believe that SimplyGo is an ideal choice for oxygen users who are active or like to travel.”

    Although the FAA and other international aviation regulatory bodies allow the use of approved portable oxygen concentrators on commercial airlines, many domestic and international carriers have additional requirements including advance notification, and possession of a physician’s letter and oxygen prescription. Oxygen users planning to fly with SimplyGo should contact their airline well in advance of travel.

    SimplyGo is part of the Philips Respironics Right Fit family of oxygen products that also includes the EverFlo stationary concentrator and the UltraFill home oxygen filling system. For more information, visit: www.philips.com/ReadySetSimplyGo.

    Royal Philips Electronics (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2011 sales of EUR 22.6 billion and employs approximately 121,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming, home and portable entertainment and oral healthcare. News from Philips is located at www.philips.com/newscenter.

    SUMMARY: This action amends the FAA’s rules for permitting limited use

    of portable oxygen concentrator systems on board aircraft, to allow for

    the use of additional portable oxygen concentrator (POC) devices on

    board aircraft, provided certain conditions in the SFAR are met. This

    action is necessary to allow all POC devices deemed acceptable by the

    FAA for use in air commerce to be available to the

    [[Page 63218]]

    traveling public in need of oxygen therapy. Passengers will be able to

    carry these devices on board the aircraft and use them with the

    approval of the aircraft operator.

    DATES: Effective October 31, 2012.

    FOR FURTHER INFORMATION CONTACT: For technical questions concerning

    this action, contact DK Deaderick, Air Transportation Division, AFS-

    200, Flight Standards Service, Federal Aviation Administration, 800

    Independence Avenue SW., Washington, DC 20591; telephone 202-167-8166;

    email DK.Deaderick@faa.gov.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA is authorized to issue this final rule pursuant to 49

    U.S.C. 44701. Under that section, the FAA is authorized to establish

    regulations and minimum standards for other practices, methods, and

    procedures the Administrator finds necessary for air commerce and

    national security.

    Background

    On July 12, 2005, the FAA published Special Federal Aviation

    Regulation 106 (SFAR 106) entitled, “Use of Certain Portable Oxygen

    Concentrator Devices Onboard Aircraft” (70 FR 40156). SFAR 106 is the

    result of a notice the FAA published in July 2004 (69 FR 42324) to

    address the needs of passengers who must travel with medical oxygen.

    Before publication of SFAR 106, passengers in need of medical oxygen

    during air transportation faced many obstacles when requesting service.

    Many aircraft operators did not provide medical oxygen service aboard

    flights, and those that did often provided service at a price that

    travelers could not afford. Coordinating service between operators and

    suppliers at airports was also difficult, and passengers frequently

    chose not to fly because of these difficulties.

    Medical oxygen technologies approved by the Food and Drug

    Administration (FDA) reduce the risks typically associated with

    compressed oxygen and provide a safe alternative for passengers who

    need oxygen therapy. Numerous manufacturers have developed small

    portable oxygen concentrators (POC) that work by separating oxygen from

    nitrogen and other gases contained in ambient air and dispensing it in

    concentrated form to the user with an oxygen concentration of about

    90%. The POCs operate using either rechargeable batteries or, if the

    aircraft operator obtains approval from the FAA, aircraft electrical

    power.

    In addition, the Pipeline and Hazardous Materials Safety

    Administration (PHMSA) has determined that the POCs covered by this

    amendment are not hazardous material. Thus, they do not require the

    same level of special handling as compressed oxygen, and are safe for

    use on board aircraft, provided certain conditions for their use are

    met.

    SFAR 106 permits passengers to carry on and use certain POCs on

    board aircraft if the aircraft operator ensures that the conditions

    specified in the SFAR for their use are met. The devices initially

    determined acceptable for use in SFAR 106, published July 12, 2005,

    were AirSep Corporation’s LifeStyle and Inogen, Inc.’s Inogen One POCs.

    SFAR 106 has been amended several times to allow passengers to use

    additional devices. This final rule adds additional POC devices,

    including AirSep Corporation’s Focus, AirSep FreeStyle 5, Inogen One

    G3, Inova Labs, Inc.’s LifeChoice Activox, Phillips Respironics Simply

    Go, Precision Medical Inc.’s EasyPulse and SeQual Technologies, Inc.’s

    SAROS that may be carried on and used by a passenger on board an

    aircraft.

    In addition, on January 27, 2012 (77 FR 4219), the FAA published a

    Technical Amendment to update the names of two approved POC

    manufacturers due to business changes. The LifeChoice POC is currently

    being manufactured by Inova Labs, Inc. and the RS-00400 POC is

    currently being manufactured by Oxus, Inc. In the technical amendment,

    the FAA inadvertently removed the previous manufacturer’s names from

    the list of approved POCs in SFAR 106. People still have POCs marked

    with those manufacturer’s names. In this final rule, the FAA will add

    those previous manufacturer’s names (International Biophysics

    Corporation’s LifeChoice and Delphi Medical Systems’ RS-00400) back to

    the list of approved POCs in SFAR 106.

    Aircraft operators can meet certain conditions and allow passengers

    to carry on and use one of the POC devices covered in SFAR 106. SFAR

    106 is an enabling rule, which means that no aircraft operator is

    required to allow passengers to operate these POC devices on board its

    aircraft, but it may allow them to be operated on board. If one of

    these devices is allowed by the aircraft operator to be operated on

    board, the conditions in the SFAR must be met.

    When SFAR 106 was published, the FAA committed to establishing a

    single performance standard for all POCs so the regulations wouldn’t

    apply to specific manufacturers and models of device. Whenever

    possible, the FAA tries to regulate by creating performance-based

    standards rather than approving by manufacturer. In the case of SFAR

    106, the most efficient way to serve both the passenger and the

    aircraft operator was to allow the use of the devices determined to be

    acceptable by the FAA in SFAR 106 in a special, temporary regulation.

    As the FAA stated in the preamble discussion of the final rule that

    established SFAR 106, “while we are committed to developing a

    performance-based standard for all future POC devices, we do not want

    to prematurely develop standards that have the effect of stifling new

    technology of which we are unaware.” The FAA developed and published

    SFAR 106 so passengers who otherwise could not fly could do so with an

    affordable alternative to what existed before SFAR 106 was published.

    The FAA continues to pursue the performance-based standard for all

    POCs. This process is time-consuming, and the FAA intends to publish a

    notice in the Federal Register and offer the public a chance to comment

    on the proposal when it is complete. In the meantime, manufacturers

    continue to create new and better POCs, and manufacturers have

    requested that their product also be included as an acceptable POC in

    SFAR 106. Precision Medical, Inc., Inogen, Inc. and AirSep Corporation

    have formally submitted petitions for exemption to the FAA that would

    allow their POCs to be used on aircraft. In addition, SeQual

    Technologies, Inc., Inova Labs, Inc., and Phillips Respironics have

    submitted requests for approval and addition to SFAR 106, with all

    required documentation for their POCs, to the Department of

    Transportation’s Docket Management System.

    Additionally, as stated in Section 2 of SFAR 106, no covered device

    may contain hazardous materials as determined by PHMSA (written

    documentation necessary), and each device must also be regulated by the

    FDA. All manufacturers have included technical specifications for their

    devices in each request for approval, as well as the required

    documentation from PHMSA and the FDA.

    The Rule

    This amendment to SFAR 106 will include the AirSep Focus, AirSep

    FreeStyle 5, Inogen One G3, Inova Labs LifeChoice Activox, Respironics

    Simply Go, Precision Medical EasyPulse and SeQual SAROS devices in the

    list of POC devices authorized for use in air commerce. The FAA has

    reviewed these devices and accepted the

    [[Page 63219]]

    documentation provided by the manufacturers. That documentation

    includes letters provided to the manufacturer by PHMSA and the FDA

    affirming the status of the device as it applies to the requirements

    stated in SFAR 106. After reviewing the applicable FDA safety standards

    and the PHMSA findings, the device was determined by the FAA to be

    acceptable for use in air commerce.

    Additionally, in the January 27, 2012 technical amendment to SFAR

    106, while updating manufacturer’s names due to business changes, the

    FAA inadvertently removed the previous manufacturer’s names from the

    list of approved POCs. Even though these POCs are manufactured under

    new manufacturer’s names, people still have POCs marked with the

    previous manufacturer’s names. In this final rule, the FAA will add

    those previous manufacturer’s names (International Biophysics

    Corporation’s LifeChoice and Delphi Medical Systems’ RS-00400) back to

    the list of approved POCs in SFAR 106.

    Waiver of Notice of Proposed Rulemaking and Delay in Effective Date

    Section 553 of the Administrative Procedure Act, 5 U.S.C

    553(b)(3)(B), provides that, when an agency for good cause finds that

    notice and public procedure are impracticable, unnecessary, or contrary

    to the public interest, the agency may issue a rule without providing

    notice and an opportunity for public comment. We have determined that

    there is good cause for making the rule final without prior proposal

    and opportunity for comment because the issues related to the use of

    POC devices on board aircraft have already been discussed as part of an

    earlier rulemaking. More specifically, on July 14, 2004, the FAA issued

    a notice of proposed rulemaking on the use of portable oxygen

    concentrator devices on board aircraft (69 FR 42324). Then, on July 12,

    2005, after reviewing public comments received, the FAA published

    Special Federal Aviation Regulation 106 (SFAR 106) entitled, “Use of

    Certain Portable Oxygen Concentrator Devices on Board Aircraft.” (70

    FR 40156) Therefore, it is unnecessary and contrary to the public

    interest to publish a notice requesting comments on this amendment.

    Moreover, pursuant to 5 U.S.C.553(d)(3), we find that good cause

    exists for making this rule effective in less than 30 days. This rule

    is being made effective 15 calendar days after its publication in the

    Federal Register to prevent unnecessary delay in acceptance of these

    devices as authorized for use on board aircraft by airlines while still

    providing airlines adequate notice and time to ensure the devices can

    be used safely on board aircraft. We believe, based on information the

    Department has received from airlines, that fifteen calendar days is

    sufficient amount of time for an airline to ensure/confirm that an FAA-

    approved POC does not cause interference with avionics system on that

    carrier’s aircraft and convey this information to the appropriate

    airline personnel in order to accept these devices on board aircraft

    for use by passengers who need oxygen therapy for air travel. As such,

    the FAA believes that good cause exists for making this rule effective

    15 calendar days after its publication in the Federal Register.

    Regulatory Notices and Analyses

    Regulatory Evaluation

    Changes to Federal regulations must undergo several economic

    analyses. First, Executive Order 12866 and Executive Order 13563

    directs that each Federal agency shall propose or adopt a regulation

    only upon a reasoned determination that the benefits of the intended

    regulation justify its costs. Second, the Regulatory Flexibility Act of

    1980 (Pub. L. 96-354) requires agencies to analyze the economic impact

    of regulatory changes on small entities. Third, the Trade Agreements

    Act (Pub. L. 96-39) prohibits agencies from setting standards that

    create unnecessary obstacles to the foreign commerce of the United

    States. In developing U.S. standards, this Trade Act requires agencies

    to consider international standards and, where appropriate, that they

    be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform

    Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written

    assessment of the costs, benefits, and other effects of proposed or

    final rules that include a Federal mandate likely to result in the

    expenditure by State, local, or tribal governments, in the aggregate,

    or by the private sector, of $100 million or more annually (adjusted

    for inflation with base year of 1995). This portion of the preamble

    summarizes the FAA’s analysis of the economic impacts of this final

    rule.

    Department of Transportation Order DOT 2100.5 prescribes policies

    and procedures for simplification, analysis, and review of regulations.

    If the expected cost impact is so minimal that a proposed or final rule

    does not warrant a full evaluation, this order permits that a statement

    to that effect and the basis for it be included in the preamble if a

    full regulatory evaluation of the cost and benefits is not prepared.

    Such a determination has been made for this final rule. The reasoning

    for this determination follows:

    This action amends SFAR 106 to allow for the use of additional POC

    devices on board aircraft, provided certain conditions in the SFAR are

    met. This action is necessary to allow additional POC devices deemed

    acceptable by the FAA to be available to the traveling public in need

    of oxygen therapy, for use in air commerce. When this rule becomes

    effective, there will many different POC devices the FAA finds

    acceptable for use on board aircraft, and passengers will be able to

    carry these devices on board the aircraft and use them with the

    approval of the aircraft operator. As the rule increases the number of

    acceptable POC devices on board aircraft, the rule does not increase

    costs and provides additional benefits. The FAA has, therefore,

    determined that this final rule is not a “significant regulatory

    action” as defined in section 3(f) of Executive Order 12866, and is

    not “significant” as defined in DOT’s Regulatory Policies and

    Procedures.

    Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)

    establishes “as a principle of regulatory issuance that agencies shall

    endeavor, consistent with the objectives of the rule and of applicable

    statutes, to fit regulatory and informational requirements to the scale

    of the businesses, organizations, and governmental jurisdictions

    subject to regulation. To achieve this principle, agencies are required

    to “solicit and consider flexible regulatory proposals and to explain

    the rationale for their actions to assure that such proposals are given

    serious consideration.” The RFA covers a wide-range of small entities,

    including small businesses, not-for-profit organizations, and small

    governmental jurisdictions.

    Agencies must perform a review to determine whether a rule will

    have a significant economic impact on a substantial number of small

    entities. If the agency determines that it will, the agency must

    prepare a regulatory flexibility analysis as described in the RFA.

    However, if an agency determines that a rule is not expected to

    have a significant economic impact on a substantial number of small

    entities, section 605(b) of the RFA provides that the head of the

    agency may so certify and a regulatory flexibility analysis is not

    required. The certification must include a statement providing the

    [[Page 63220]]

    factual basis for this determination, and the reasoning should be

    clear.

    This final rule adds additional POC devices to the list of

    authorized POC devices in SFAR 106. This economic impact is minimal.

    Therefore, as the Acting FAA Administrator, I certify that this action

    will not have a significant economic impact on a substantial number of

    small entities.

    Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-

    4) requires each Federal agency to prepare a written statement

    assessing the effects of any Federal mandate in a proposed or final

    agency rule that may result in an expenditure of $100 million or more

    (in 1995 dollars) in any one year by State, local, and tribal

    governments, in the aggregate, or by the private sector; such a mandate

    is deemed to be a “significant regulatory action.” The FAA currently

    uses an inflation-adjusted value of $143.1 million in lieu of $100

    million. This final rule does not contain such a mandate; therefore,

    the requirements of Title II of the Act do not apply.

    Paperwork Reduction

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires

    that the FAA consider the impact of paperwork and other information

    collection burdens imposed on the public. According to the 1995

    amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an

    agency may not collect or sponsor the collection of information, nor

    may it impose an information collection requirement unless it displays

    a currently valid Office of Management and Budget (OMB) control number.

    Information collection requirements associated with this final rule

    have been approved previously by the Office of Management and Budget

    (OMB) under the provisions of the Paperwork Reduction Act of 1995 (44

    U.S.C. 3507(d)) and have been assigned OMB Control Number 2120-0702.

    This final rule requires that if a passenger carries a POC device on

    board the aircraft with the intent to use it during the flight, he or

    she must inform the pilot in command of that flight. Additionally, the

    passenger who plans to use the device must provide a written statement

    signed by a licensed physician that verifies the passenger’s ability to

    operate the device, respond to any alarms, the extent to which the

    passenger must use the POC (all or a portion of the flight), and

    prescribes the maximum oxygen flow rate. The Paperwork Reduction Act

    paragraph in the final rule that established SFAR 106 still applies to

    this amendment. The availability of a new POC device will likely

    increase the availability and options for a passenger in need of oxygen

    therapy, but the paperwork burden discussed in the original final rule

    is unchanged. Therefore, the OMB Control Number associated with this

    collection remains 2120-0702.

    An agency may not conduct or sponsor, and a person is not required

    to respond to, a collection of information unless it displays a

    currently valid OMB control number.

    International Compatibility

    In keeping with U.S. obligations under the Convention on

    International Civil Aviation, it is FAA policy to conform to

    International Civil Aviation Organization (ICAO) Standards and

    Recommended Practices to the maximum extent practicable. The FAA has

    determined that there are no ICAO Standards and Recommended Practices

    that correspond to these regulations.

    International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the

    Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal

    agencies from establishing standards or engaging in related activities

    that create unnecessary obstacles to the foreign commerce of the United

    States. Pursuant to these Acts, the establishment of standards is not

    considered an unnecessary obstacle to the foreign commerce of the

    United States, so long as the standard has a legitimate domestic

    objective, such the protection of safety, and does not operate in a

    manner that excludes imports that meet this objective. The statute also

    requires consideration of international standards and, where

    appropriate, that they be the basis for U.S. standards. The FAA has

    assessed the potential effect of this final] rule and determined that

    it will have only a domestic impact and therefore will not create

    unnecessary obstacles to the foreign commerce of the United States.

    Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically

    excluded from preparation of an environmental assessment or

    environmental impact statement under the National Environmental Policy

    Act in the absence of extraordinary circumstances. The FAA has

    determined this rulemaking action qualifies for the categorical

    exclusion identified in paragraph 312f and involves no extraordinary

    circumstances.

    Executive Order Determinations

    Executive Order 13132, Federalism

    The FAA has analyzed this immediately adopted final rule under the

    principles and criteria of Executive Order 13132, Federalism. The

    agency determined that this action will not have a substantial direct

    effect on the States, or the relationship between the Federal

    Government and the States, or on the distribution of power and

    responsibilities among the various levels of government, and,

    therefore, does not have Federalism implications.

    Executive Order 13211, Regulations That Significantly Affect Energy

    Supply, Distribution, or Use

    The FAA analyzed this immediately adopted final rule under

    Executive Order 13211, Actions Concerning Regulations that

    Significantly Affect Energy Supply, Distribution, or Use (May 18,

    2001). The agency has determined that it is not a “significant energy

    action” under the executive order and it is not likely to have a

    significant adverse effect on the supply, distribution, or use of

    energy.

    How To Obtain Additional Information

    Rulemaking Documents

    An electronic copy of a rulemaking document my be obtained by using

    the Internet–

    1. Search the Federal eRulemaking Portal (http://www.regulations.gov);

    2. Visit the FAA’s Regulations and Policies Web page at http://www.faa.gov/regulations_policies/or

    3. Access the Government Printing Office’s Web page at http://www.gpo.gov/fdsys/.

    Copies may also be obtained by sending a request (identified by

    notice, amendment, or docket number of this rulemaking) to the Federal

    Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence

    Avenue SW., Washington, DC 20591, or by calling (202) 267-9680.

    Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of

    1996 requires FAA to comply with small entity requests for information

    or advice about compliance with statutes and regulations within its

    jurisdiction. A small entity with questions regarding this document,

    may contact its local FAA official, or the person listed under the FOR

    FURTHER INFORMATION CONTACT heading at the beginning of the preamble.

    People requiring a pure source of oxygen will now have new options when traveling on airplanes now that the FAA (Federal Aviation Administration) approved a bunch of oxygen concentrators to be used on commercial flights going in, out, and around the U.S.

    These include Philips Respironics’ SimplyGo (pictured), AirSep Corporation’s Focus, AirSep FreeStyle 5, Inogen One G3, Inova Labs, Inc.’s LifeChoice Activox Precision Medical Inc.’s EasyPulse and SeQual Technologies, Inc.’s SAROS. These are not the first portable oxygen concentrators approved for use in-flight; AirSep Corporation’s LifeStyle and Inogen, Inc.’s Inogen One have been allowed to fly since 2005 and some others were approved since. Nevertheless, this is important news for independence seeking oxygen users that would like more options when shopping for a device.

    Source : http://www.newscenter.philips.com/main/standard/news/press/2012/07112012-SimplyGo-FAA-approval.wpd

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  • SpinChip Combines Microfluidics and Centrifuge for Rapid Blood Analysis

    SpinChip Combines Microfluidics and Centrifuge for Rapid Blood Analysis

    SpinChip Combines Microfluidics and Centrifuge for Rapid Blood Analysis

    SpinChip Diagnostics AS develops game-changing lab-on-a-chip technology for point of care use.

    Features:

    • Fast and easy in use

    • Fully automated sample processing + assays in < 2 minutes

    • Sample volume 1 µL to 1 mL

    • Extremely fast separation (e.g. plasma from cell in10 µL whole blood)

    • Forced interaction between reactants

    • Numerous fields of application (proteins, cells, DNA/RNA, drugs, nutrients…)

    • No pumps, valves or any other chip restricting interfaces

    • Automated volume metering, splitting, mixing…all within the chip

    • Multiplexing

    • High quality quantitative assays with wide sensitivity range

    • Closed lab-on-a-chip system including sampling device

    • Liquid and dried reagents on chip

    • Compact and low cost. Instrument = 1.6 dm3, Chip: D = 4.5 cm

    • Robust and reliable technologies

    The Norwegian company SpinChip aims to help doctors analyse patients’ blood samples on the spot and provide immediate results.

    In SpinChip, the blood sample is drawn directly from the patient’s fingertip into small analytical chips that are placed in a microcentrifuge. (Foto: SpinChip)

    Early, correct diagnoses are often of decisive importance in hindering the development of serious ailments. The results of analyses of patient samples (blood, urine, etc.) can be an important element diagnosing illnesses.

    In most cases, such samples must be sent to a laboratory for analysis, with the result that important information may not be available at the start of treatment.

    Doctors’ surgeries are already equipped with a number of analytical instruments, but their range of applications is extremely limited. There is need for a compact, robust, reliable but highly sensitive machine that can perform a wide range of analyses, but is not too expensive.

    Advanced microfluidics

    In SpinChip, the blood sample is drawn directly from the patient’s fingertip into small analytical chips that are placed in a microcentrifuge. Inside the chip, the fluids and dry components of the sample are separated, launching a number of reactions that take place in a series of tiny channels without any need for pumps or valves; i.e. high-level microfluidics. The results are read out optically within a couple of minutes.

    While current solutions have only a limited repertoire of analyses and are sometimes unreliable, the SpinChip technology has the potential to perform a wide range of analyses rapidly, simply and reliably. The analytical technology will be available in a portable instrument, so that critical bioanalyses can be moved from the laboratory to hospital emergency departments, bedsides and doctors’ surgeries, making it easier to start the right treatment sooner than would otherwise be possible.

    The technology was invented by SINTEF senior scientist Stig Morten Borch, and developed for commercialisation with the help of internal SINTEF funding (SEP projects) and funds from the Research Council of Norway’s FORNY Programme.

    Further development

    SpinChip was registered as a company in February this year. SINTEF has licensed the technology along with two patents, and has signed up Tronrud Engineering as a co-investor. Although the company currently has no employees, Borch has been hired on contract, and services are being purchased from SINTEF and Tronrud Engineering.

    From now and until 2015, the technology will continue to be developed, and the Research Council of Norway has contributed to financing efforts via a User-driven Research-based Innovation (BIA) project that is currently being launched.

    “In the course of 2013, SpinChip Diagnostics will start to hire its own staff, and in the first quarter of the year we will also invite new investors to join the company. We have about 20 investors in our sights,” says Jostein Bjøndal in SINVENT, SINTEF’s research commercialisation company.

    New technology being developed by scientists in Norway may bring rapid blood testing directly to the bedside. The SpinChip, invented by Stig Morten Borch of Norway’s SINTEF research center, uses a centrifuge to spin a small microfluidic chip that separates a blood sample into solid and liquid components that then undergo chemical reactions within the chip’s narrow channels. Within minutes of activating the centrifuge, an optical sensor reads the results of the reactions and provides output to the clinician.

    The technology is continuing to be developed by a newly formed spinoff firm SpinChip Diagnostics AS, which plans to spend the next couple of years getting a viable product ready for commercialization.

    While current solutions have only a limited repertoire of analyses and are sometimes unreliable, the SpinChip technology has the potential to perform a wide range of analyses rapidly, simply and reliably. The analytical technology will be available in a portable instrument, so that critical bioanalyses can be moved from the laboratory to hospital emergency departments, bedsides and doctors’ surgeries, making it easier to start the right treatment sooner than would otherwise be possible.

    Source : http://www.sintef.no/home/Press-Room/Research-News/SpinChip-analyses-blood-samples-on-the-spot/

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  • IBA’s Proton Therapy with Philips Ambient Experience

    IBA’s Proton Therapy with Philips Ambient Experience

    IBA’s Proton Therapy with Philips Ambient Experience

    BOSTON, October 28, 2012 — IBA Group, a leader in advanced cancer diagnosis and therapy technologies, and Royal Philips Electronics (NYSE: PHG, AEX: PHI) today announced their first-ever installation of a state-of-the-art, patient-centered proton therapy treatment room in the United States. A new addition to the Willis-Knighton Cancer Center in Shreveport, La., will be the first IBA installation to incorporate the Philips Ambient Experience.

    Designed and engineered by Philips Healthcare, the Philips Ambient Experience promotes patient relaxation during proton treatments by permitting patients to selectively add comforting light, sound and images to the treatment room environment before they begin therapy. This will help improve the patient and staff experience, turning a cold, impersonal environment into one that comforts and reassures as the patient becomes an active participant in the process.

    “This new installation is the first to come to fruition from the Philips-IBA cooperative agreement,” said Olivier Legrain, Chief Executive Officer at IBA. “It is demonstrative of a successful collaboration with Philips in offering highly advanced, patient-centered care, and we are delighted it will be integrated into our new proton system installations.”

    “Ambient Experience enhances our ability to provide superior cancer care,” said Dr. Lane Rosen of the Willis-Knighton Cancer Center. “The soothing and empowering atmosphere will make our patients more comfortable, which will allow our staff to work more efficiently. IBA and Philips have been excellent partners, so it made sense to work with them to bring this unique experience to our patients.”

    Willis-Knighton will be the first center to utilize Proteus®ONE, IBA’s single-room compact gantry solution for those looking for a more cost-effective, smaller footprint option. The $40 million project is expected to begin treating cancer patients with protons in early 2014.

    Together with Philips, IBA is demonstrating a life-size model of the ProteusONE proton therapy room combined with the Philips Ambient Experience solution in booth #3019 at the 54th annual meeting of ASTRO, the American Society for Radiation Oncology, in Boston.

    IBA Group (Louvain-la-Neuve, Belgium) has partnered with Philips to create an attractive new patient experience for their proton therapy system. Upon entering the facility patients choose the music, visuals, and lighting they prefer via a tablet. This is built on the foundations of the Philips Ambient Experience, a set of principles and design ideas that aim to turn diagnostic imaging and therapy sessions into a less anxiety inducing experience.

    The first such system is being installed at the Willis-Knighton Cancer Center in Shreveport, Louisiana.

    Source : http://www.newscenter.philips.com/main/healthcare/news/press/2012/20121028-Philips-and-IBA.wpd

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Latest News

  • Global Dental Clinic Cabinet Consumption Market 2016 Clinical Trend,Review 2025

    Global Dental Clinic Cabinet Consumption Market 2016 Clinical Trend,Review 2025

    05 Dec 2016

    Dental-Clinic-Cabinet-Consumption-200-200

    The Global Dental Clinic Cabinet Consumption Market analysis report contains all study material about Global Dental Clinic Cabinet Consumption Market Overview, Clinical Review, Medical Trend, Demand and Development Research in all over the world. The report, named “Global Dental Clinic Cabinet Consumption Market”, provides a Detailed overview of the Dental Clinic Cabinet Consumption market related to overall world. Report assesses the size of the Dental Clinic Cabinet Consumption market and also estimates the valuation of the Global Dental Clinic Cabinet Consumption market by the end of the given forecast period.

    Global Dental Clinic Cabinet Consumption Market Sample Report 2016 

    Worldwide report on ” Dental Clinic Cabinet Consumption Market” includes a comprehensive study of the Dental Clinic Cabinet Consumption market and defines the key terminologies as well as Dental Clinic Cabinet Consumption market classifications for the benefit of new entrants to the Worldwide Dental Clinic Cabinet Consumption market. This report points out the Dental Clinic Cabinet Consumption Market drivers and restraints affecting the growth of the Dental Clinic Cabinet Consumption market. It also cites the various Dental Clinic Cabinet Consumption Industry opportunities for the Dental Clinic Cabinet Consumption market to grow in the next couple of years.

    The report studies the global Dental Clinic Cabinet Consumption market on the basis of major product types and end user segments. The report related to Dental Clinic Cabinet Consumption Market also compiles data from relevant industry bodies to forecast the growth of each of the segments related Dental Clinic Cabinet Consumption Market Scenario. The report especially focuses on Dental Clinic Cabinet Consumption market and analyzes the various micro- and macro-economic factors affecting the growth of the global Dental Clinic Cabinet Consumption market. Presently, the global Dental Clinic Cabinet Consumption industry economy is witnessing its slowest growth phase in the past two decades related Dental Clinic Cabinet Consumption market scenario.

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    The report profiles some of the key players in the global Dental Clinic Cabinet Consumption market and provides insightful information about Dental Clinic Cabinet Consumption industry, such as business overview, Dental Clinic Cabinet Consumption market product segmentation, revenue segmentation, and latest developments. The report Dental Clinic Cabinet Consumption market analyzes the strengths and weaknesses of the key players through SWOT analysis and projects the Dental Clinic Cabinet Consumption market growth of the key players during the forecast period. The report on ” Worldwide Dental Clinic Cabinet Consumption Industry ” also provides some valuable recommendations and serves as a helpful guide to new as well as existing players in the Dental Clinic Cabinet Consumption market.

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    QY Market Research is a single destination for all the industry, company and country reports. We feature large repository of latest industry reports, leading and niche company profiles, and market statistics released by reputed private publishers and public organizations.

  • Mindray Introduces L20-5s Ultra-High Frequency Linear Transducer with Enhanced iNeedle Visualization Technology

    Mindray Introduces L20-5s Ultra-High Frequency Linear Transducer with Enhanced iNeedle Visualization Technology

    05 Dec 2016

    transducer

     

    Mindray recently announced the launch of the L20-5s ultra-high frequency linear transducer with enhanced iNeedle visualization technology. This transducer technology leverages the firm’s TE7 point-of-care ultrasound system. This recent innovation in ultrasound technology provides exquisite image quality of soft tissues while preserving visualization of needles used in procedures.

    This technology is being targeted at anesthesiologists for use in regional nerve blocks and in placement of ultrasound-guided central lines. Mindray is making a push to improve image quality and usability while reducing procedure time for clinicians in high-stress critical applications such operating rooms, interventional suits, and the intensive care unit. It will be interesting to see the adoption of specialized transducer technologies as use of ultrasound expands owing to portability and lack of reliance on ionizing radiation.

    ineedle

    Via: Mindray…

  • Obalon Non-Surgical Weight Loss System: Interview with Andy Rasdal, CEO of Obalon Therapeutics.

    Obalon Non-Surgical Weight Loss System: Interview with Andy Rasdal, CEO of Obalon Therapeutics.

    05 Dec 2016

    obalon

     

    Medgadget recently reported on the FDA approval of the Obalon balloon system, which assists weight-loss in obese patients who have failed to lose weight by other means and is an alternative to conventional gastric bypass surgery. The system has been developed by Obalon Therapeutics, a company out of Carlsbad, California, and consists of inflatable balloons that can be inserted into the stomach in a minimally invasive manner. The treatment involves swallowing a deflated balloon in the form of a small capsule attached to a thin tube. Once in the stomach, the balloon is inflated and the tube is withdrawn. A maximum of up to three balloons can be placed in the stomach, to be left in place for up to six months before deflation and removal using an endoscopic procedure. The balloons contribute a feeling of satiety, meaning that patients tend to eat less and lose weight.

    Medgadget had the opportunity to ask Andy Rasdal, CEO of Obalon Therapeutics some questions about the Obalon balloon system.

     

    Conn Hastings, Medgadget: Congratulations on the recent FDA approval of the Obalon system. Can you give us a brief overview as to how the system compares with other treatments for obese patients?

    balloonAndy Rasdal, Obalon Therapeutics: Thank you. The FDA PMA approval of the Obalon Balloon System came only after rigorous FDA review and the successful completion of a double-blinded, randomized, sham-controlled trial that met its co-primary weight loss endpoints and demonstrated a strong safety profile. The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise.

    The Obalon Balloon is a very different technology platform than the other two gastric balloons currently approved in the U.S. – the ReShape Duo and the Apollo Orbera. For ReShape and Apollo, a single balloon is placed in the stomach via an endoscopic procedure under anesthesia and filled with liquid. In contra st, the Obalon Balloon is swallowed in a dissolvable capsule without the need for anesthesia and filled with gas. Up to three balloons may be swallowed and placed during the therapy period. At Obalon, our design intent was to create a gastric balloon that minimized side effects and provided progressive weight loss over the full six-month treatment period.

     

    Medgadget: Gastric bypass surgery produces a permanent change in the architecture of the gastrointestinal tract, whereas the balloon system is removed after 6 months. Is there a risk that patients could regain weight once the system is removed, or do lasting changes in lifestyle occur?

    Andy Rasdal: We studied that in our U.S. Pivotal Trial that support FDA approval and the data was presented on November 4, 2014 by Dr. Aurora Pryor in a scientific session at Obesity Week. Dr. Pryor presented that at the end of one year, six months after the balloons were removed, patients had maintained 89.5% of their weight loss on average.

     

    Medgadget: How was the balloon system conceived?

    Andy Rasdal: We started Obalon more than eight years ago with the intent to invent a novel, non-surgical and fully reversible device that would give overweight and obese people a safe and effective option to reverse the progress of this chronic disease. Obalon did not invent the idea of a space-occupying device for weight loss, or even concept the gastric balloon, but Obalon has invented the first and only swallowable, gas-filled balloon approved by the FDA.

    The Obalon Balloon is intended to occupy space in the stomach to make patients feel full sooner, eat less and lose weight. In addition to the strong safety and efficacy demonstrated in our US Pivotal Trial that supported our FDA approval, we believe the Obalon Balloon offers many important ease-of-use advantages over prior and current gastric balloons to both providers and patients.

    First, by being swallowable, the Obalon Balloon is easy to place – a patient simply swallows the capsule with the balloon inside without anesthesia or sedation. Placement does not require an endoscopic procedure under anesthesia like other gastric balloons. The simple placement enables balloon volume to be increased incrementally over the treatment period by simply swallowing up to two more additional balloon capsules, which is intended to minimize side effects and create progressive weight loss over the full treatment period.

    Next, by being gas-filled, the balloon is light and floats up in the fundus, or top of the stomach, as opposed to sinking to the antrum, or bottom of the stomach, like other prior and current gastric balloons. This is intended to be less offensive to the stomach to increase patient comfort and reduce the adverse events seen with conventional liquid-filled balloons.

    Creating a swallowable, gas-filled balloon required the invention of first of its kind technology. Our multi-layer balloon film is thin enough to fit into a swallowable capsule, but robust enough to withstand the chemical and mechanical forces of the stomach trying to digest it. Our balloon is filled with a proprietary mix of gas, which along with a novel inflation valve, ensure full balloon inflation throughout the full six-month treatment period. Finally, we have developed unique capsule and catheter technology that enables the balloon to be reliably delivered to and inflated in the stomach.

     

    Medgadget: Are the balloons well tolerated? This sounds like a procedure with much less morbidity and risk than a gastric bypass. Is that a fair assessment?

    In the U.S. Pivotal Trial, there was only a single serious adverse event (0.3% of patients) that was related to a patient who took contraindicated anticoagulants after outpatient knee replacement surgery during the trial. Overall, the Obalon Balloon was very well tolerated and more than 80% of all adverse events were rated as mild.

     

    Medgadget: The system reduces hunger by producing a feeling of fullness in the stomach when food is consumed. Is this the primary consideration in hunger, or do other factors like blood sugar levels or psychological issues also play a role?

    Andy Rasdal: The mechanism of weight loss, especially related to the different modalities, is a complex interaction of both physiological and psychological factors. I believe the simplest explanation of how the Obalon Balloon works is that its intended to occupy space in the stomach to make patients feel full sooner, eat less and lose weight. It is not a magic pill and requires the patient to make behavioral changes, hopefully as part of a structured diet and exercise program provided in conjunction with the balloon therapy.

     

    Medgadget: Can a second round of balloon treatment be implemented, if required?

    Andy Rasdal: Obalon has not studied the safety and efficacy of successive balloon treatments at this time, so we cannot comment scientifically.

    divider

    Product page: Obalon Balloon System…

  • ExactVu Micro-Ultrasound System for Prostate Imaging and Biopsy Guidance Cleared in Europe

    ExactVu Micro-Ultrasound System for Prostate Imaging and Biopsy Guidance Cleared in Europe

    05 Dec 2016

    exact-imaging-system

    Exact Imaging, a Canadian firm, won the European CE Mark to introduce its ExactVu prostate imaging and biopsy guidance system to the European market. It is a micro-ultrasound system that provides a resolution down to 70 microns, allowing a physician to visualize the prostate in real time and in high detail. The ExactVu relies on a 29 MHz transducer that is placed directly against the prostate to identify suspect lesion that should be sampled in a biopsy and to help guide the biopsy to the target location.

    Besides the high resolution probe that’s inserted through the rear, the system comes with two conventional trans-abdominal probes for kidney, bladder, and prostate imaging. And it includes an integrated disposable biopsy device for a complete package that can be quickly introduced into the clinic.

    The unit itself has an adjustable control panel and a touchscreen interface with a bunch of presets one can tune.

    “There is significant built-up demand for acquiring the ExactVu instrument and this approval will allow us to be able to commercialize our platform in Europe. said Randy AuCoin, Exact Imaging’s President and CEO, in a statement. “With the ExactVu platform, urologists will have a new level of real-time resolution to facilitate actually targeting their prostate biopsies at suspicious regions. The goal is to provide the best tools to help the urologist make the most informed decisions and ultimately, to improve patient outcomes.”

    Here’s a talk by Dr. Sangeet Ghaiof the University of Toronto discussing the clinical implications of micro-ultrasound:

    Link: Exact Imaging…

    Original announcement…

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Diabetes

  • PaQ Three Day Insulin Delivery Device Cleared in Europe

    PaQ Three Day Insulin Delivery Device Cleared in Europe

    The CeQur device, a small discreet, wearable insulin patch infuser, is for the continuous subcutaneous delivery of rapid acting insulin for the management of type 2 Diabetes mellitus.

    The CeQur insulin delivery device is designed to meet the specific needs of people with type 2 diabetes who could benefit from intensive insulin therapy.

    Its simple and discrete design may enable patients to more readily experience the benefits of intensive insulin therapy, all while remaining free from multiple daily injections.

    The CeQur insulin infuser includes a disposable insulin reservoir that attaches to a reusable electronic messenger. The device easily attaches to the patient’s abdominal area with a safe and secure adhesive backing. Once in place, insulin is delivered subcutaneously through a fine, soft tube or cannula from the reservoir that is changed by the patient every few days.

    The CeQur insulin delivery device is designed to use just one type of insulin for both basal and bolus dosing, and will be available in multiple basal rates.

    CeQur of Horw, Switzerland received European approval for the PaQ Insulin Delivery Device. The PaQ provides three days of continuous insulin infusion for patients with type 2 diabetes, and also offers the option for users to initiate an extra bolus injection at any time.

    The device consists of a disposable insulin container that connects to a reusable electronic component that can provide on-demand information on the status of the PaQ.

    From the company announcement:

    The CeQur insulin infuser includes a disposable insulin reservoir that attaches to a reusable electronic messenger. The device easily attaches to the patient’s abdominal area with a safe and secure adhesive backing. Once in place, insulin is delivered subcutaneously through a fine, soft tube or cannula from the reservoir that is changed by the patient every few days.

    The CeQur insulin delivery device is designed to use just one type of insulin for both basal and bolus dosing, and will be available in multiple basal rates.

    Source : http://cequrcorp.com/cequr-device/

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  • Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

    Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

    Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of BiopumpTM a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office (USPTO) protecting the use of Medgenics’ EPODURE Biopump technology for delivery of erythropoietin (EPO). Medgenics is developing EPODURE to address the need for safer, sustained treatment of anemia. The USPTO also allowed claims covering a similar method for delivery of clotting Factor VIII, underlying Medgenics’ HEMODURE™ Biopump technology for sustained prophylactic treatment of hemophilia.

    Similar claims covering EPODURE and HEMODURE have also been recently allowed in Japan, China, Korea and Australia.

    In total, Medgenics’ global portfolio now includes 36 patents issued, with 81 more pending.

    Medgenics believes its approach to protein therapy has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics’ technologies target the global protein therapy market which is forecast to reach $132 billion in 2013.

    “As we continue to progress in our clinical trials and move forward in our business development efforts, the protection of our intellectual property becomes critical. We believe that receiving method patents and allowance of key claims for our Biopump™ system for the production and delivery of EPO and Factor VIII proteins increases the value of our intellectual property assets and our company,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.

    Source : http://www.news-medical.net/news/20121122/Medgenicse28099-EPODURE-Biopump-technology-for-EPO-delivery-receives-US-patent.aspx

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  • St. Jude’s Portico Transcatheter Aortic Valve Receives CE Mark

    St. Jude’s Portico Transcatheter Aortic Valve Receives CE Mark

    St. Jude’s Portico Transcatheter Aortic Valve Receives CE Mark

    St. Jude Medical has just announced the first successful human implantation of the company’s Portico transcatheter aortic heart valve in a patient with aortic stenosis. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul’s Hospital in Vancouver, British Columbia. We hear that St.Jude is working hard to make sure the device is safe and secure, so things like perivalvular leaks and valve displacements do not happen during or after implantation. 38djjjlj St. Judes Portico Transcatheter Aortic Valve Implanted in Human (Exclusive Pics)Furthermore, the company is looking into ways to develop both transapical and transfemoral deliveries for the valve. And, in addition, the device, when it is finally approved, might feature the company’s proprietary Linx anticalcification technology that might actually prolong the life of the device and/or prevent calcium buildup and things like embolizations.

    Check our exclusive images of the device, and here’s more info about it from the announcement:

    The valve, which is made of bovine pericardial tissue, is designed to increase physicians’ control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed (the process of bringing the valve back into the delivery catheter) and retrieved before it is released from the delivery system, allowing physicians to reposition the valve at the implant site. No transcatheter valve currently on the market has the ability to be re-sheathed, repositioned, or retrieved.

    The St. Jude Medical transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. Two delivery methods will be available for the Portico valve, transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).

    Commenting on the first implant, Dr. Gregory Fontana, professor and vice chairman, Department of Surgery at the Cedars-Sinai Heart Institute in Los Angeles, Calif., said, “Many of the shortcomings of first generation devices have been addressed with the next generation St. Jude Medical Portico transcatheter valve.”

    In February 2010, St. Jude Medical announced that Dr. Fontana, and Dr. Raj Makkar, director of the Interventional Cardiology and Cardiac Catheterization Laboratory at the Cedars-Sinai Heart Institute, will be the principal investigators in the company’s transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.

    St. Jude Medical Announces European Approval of the Portico Transcatheter Aortic Heart Valve

    ST. PAUL, Minn.–(BUSINESS WIRE)–Nov. 19, 2012– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received European CE Mark approval for its 23 mm Portico™ Transcatheter Aortic Heart Valve and Transfemoral Delivery System. Designed for patients with severe aortic stenosis who are considered to be inoperable or high risk for conventional open-heart valve replacement surgery, the Portico valve is implanted through a small incision in the femoral artery (the main artery of the leg). The procedure uses a catheter placed percutaneously (through the skin) to deliver and position the valve in the heart and occurs while the heart continues to beat. This avoids the need to place the patient on cardiopulmonary bypass, a process in which a machine takes over heart and lung function during surgery.

    23 mm Portico(TM) Transcatheter Aortic Heart Valve – Image courtesy of St. Jude Medical.

    23 mm Portico(TM) Transcatheter Aortic Heart Valve – Image courtesy of St. Jude Medical.

    The Portico device is the only approved transcatheter valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system. The valve was designed in collaboration with leading physicians to address limitations of current-generation devices by improving control and accuracy in positioning and placement of the valve, minimizing paravalvular leak (a common complication with first-generation transcatheter valves) and potentially reducing the need for the implantation of a permanent pacemaker after the procedure.

    “The ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves,” said Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. “This is particularly helpful in ensuring accurate placement of the valve and minimizing complications for this high risk population.”

    Featuring leaflets made of bovine pericardial tissue attached to a self-expanding stent, the Portico valve was designed to help increase physician control and placement accuracy during deployment of the valve.

    “The European approval of the Portico transcatheter valve signals the imminent availability of a next-generation treatment option that can help improve quality of life for patients with diseased or damaged aortic heart valves,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “It also represents a key milestone for St. Jude Medical’s transcatheter heart valve program, and exemplifies our focus on developing technologies that advance the practice of medicine.”

    Dr. Manoharan recently presented first-in-human (FIH) 12-month data demonstrating the safety and efficacy of the Portico transcatheter heart valve at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. In the study, there were no vascular complications, major strokes or deaths among study patients and no new pacemakers required. Clinical improvements that were noted at earlier follow-up intervals were sustained out to 12 months (including valve function).

    St. Jude Medical also intends to begin a European study of the 25 mm valve to support CE Mark approval before the end of the year.

    For additional information about the Portico valve visit SJMPortico.com.

    About St. Jude Medical

    St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

    Comprehensive Approach, Accurate Placement

    The Portico system provides a unique, truly comprehensive approach to aortic valve implantation designed to optimize outcomes with:

    Full resheathability*

    Positioning flexibility to improve placement accuracy

    Minimal protrusion into the LVOT

    Ability to retrieve* the valve if needed

    Targeted Placement

    Uniquely Designed for Positioning to Address the Risk of Heart Block and PV Leak

    Designed to address conduction system interference by placing the valve low within the stent frame which allows for sealing without the valve extending deep into the LVOT

    The large cells in the annulus section of the stent are designed to minimize the risk of PV Leak:

    Less metal – minimizing the potential of a stent strut resting against a calcific nodule

    More tissue – allowing the tissue to conform around calcific nodules

    Efficient Loading and Prep

    Unique loading tools allow for fast and easy valve loading and prep

    Loading and prep are performed at room temperature

    Total rinse time for the valve is only 20 seconds

    Source : http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1760178

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  • NIH-funded scientists develop new treatment to combat autoimmune disorders in mouse model

    NIH-funded scientists develop new treatment to combat autoimmune disorders in mouse model

    In a mouse model of multiple sclerosis (MS), researchers funded by the National Institutes of Health have developed innovative technology to selectively inhibit the part of the immune system responsible for attacking myelin-the insulating material that encases nerve fibers and facilitates electrical communication between brain cells.

    Autoimmune disorders occur when T-cells-a type of white blood cell within the immune system-mistake the body’s own tissues for a foreign substance and attack them. Current treatment for autoimmune disorders involves the use of immunosuppressant drugs which tamp down the overall activity of the immune system. However, these medications leave patients susceptible to infections and increase their risk of cancer as the immune system’s normal ability to identify and destroy aberrant cells within the body is compromised.

    Supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH, Drs. Stephen Miller and Lonnie Shea at Northwestern University, Evanston, teamed up with researchers at the University of Sydney, and the Myelin Repair Foundation in Saratoga, Calif. to come up with a novel way of repressing only the part of the immune system that causes autoimmune disorders while leaving the rest of the system intact.

    The new research takes advantage of a natural safeguard employed by the body to prevent autoreactive T-cells-which recognize and have the potential to attack the body’s healthy tissues-from becoming active. They report their results in the Nov. 18 online edition of Nature Biotechnology.

    “We’re trying to do something that interfaces with the natural processes in the body,” said Shea. “The body has natural mechanisms for shutting down an immune response that is inappropriate, and we’re really just looking to tap into that.”

    One of these natural mechanisms involves the ongoing clearance of apoptotic, or dying, cells from the body. When a cell dies, it releases chemicals that attract specific cells of the immune system called macrophages. These macrophages gobble up the dying cell and deliver it to the spleen where it presents self-antigens-tiny portions of proteins from the dying cell-to a pool of T-cells. In order to prevent autoreactive T-cells from being activated, macrophages initiate the repression of any T-cells capable of binding to the self-antigens.

    Dr. Miller was the first to demonstrate that by coupling a specific self-antigen such as myelin to apoptotic cells, one could tap into this natural mechanism to suppress T-cells that would normally attack the myelin. The lab spent decades demonstrating that they could generate antigen-specific immune suppression in various animal models of autoimmune diseases. Recently, they initiated a preliminary clinical trial with collaborators in Germany to test the safety of injecting the antigen-bound apoptotic cells into patients with MS. While the trial successfully demonstrated that the injections were safe, it also highlighted a key problem with using cells as a vehicle for antigen delivery:

    “Cellular therapy is extremely expensive as it needs to be carried out in a large medical center that has the capability to isolate patient’s white blood cells under sterile conditions and to re-infuse those antigen-coupled cells back into the patients,” said Miller. “It’s a costly, difficult, and time-consuming procedure.”

    Thus began a collaboration with Dr. Shea, a bioengineer at Northwestern University, to discuss the possibility of developing a surrogate for the apoptotic cells. After trying out various formulations, his lab successfully linked the desired antigens to microscopic, biodegradable particles which they predicted would be taken up by circulating macrophages similar to apoptotic cells.

    Much to their amazement, when tested by the Miller lab, the antigen-bound particles were just as good, if not better, at inducing T-cell tolerance in animal models of autoimmune disorders.

    Using their myelin-bound particles, the researchers were able to both prevent the initiation of MS in their mouse model as well as inhibit its progression when injected immediately following the first sign of clinical symptoms.

    The research team is now hoping to begin phase I clinical trials using this new technology. The material that makes up the particles has already been approved by the U.S. Food and Drug Administration and is currently used in resorbable sutures as well as in clinical trials to deliver anti-cancer agents. Miller believes that the proven safety record of these particles along with their ability to be easily produced using good manufacturing practices will make it easier to translate their discovery into clinical use.

    “I think we’ve come up with a very potent way to induce tolerance that can be easily translated into clinical practice. We’re doing everything we can now to take this forward,” said Miller.

    In addition to its potential use for the treatment of MS, the researchers have shown in the lab that their therapy can induce tolerance for other autoimmune diseases such as type I diabetes and specific food allergies. They also speculate that transplant patients could benefit from the treatment which has the potential to retract the body’s natural immune response against a transplanted organ. Dr. Christine Kelley, NIBIB director of the Division of Science and Technology, points to the unique collaboration between scientists and engineers that made this advance a reality.

    “This discovery is testimony to the importance of multidisciplinary research efforts in healthcare,” said Kelley. “The combined expertise of these immunology and bioengineering researchers has resulted in a valuable new perspective on treating autoimmune disorders.”

    Source : http://www.news-medical.net/news/20121118/NIH-funded-scientists-develop-new-treatment-to-combat-autoimmune-disorders-in-mouse-model.aspx

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  • Global Dental Clinic Cabinet Consumption Market 2016 Clinical Trend,Review 2025

    Global Dental Clinic Cabinet Consumption Market 2016 Clinical Trend,Review 2025

    Dental-Clinic-Cabinet-Consumption-200-200

    The Global Dental Clinic Cabinet Consumption Market analysis report contains all study material about Global Dental Clinic Cabinet Consumption Market Overview, Clinical Review, Medical Trend, Demand and Development Research in all over the world. The report, named “Global Dental Clinic Cabinet Consumption Market”, provides a Detailed overview of the Dental Clinic Cabinet Consumption market related to overall world. Report assesses the size of the Dental Clinic Cabinet Consumption market and also estimates the valuation of the Global Dental Clinic Cabinet Consumption market by the end of the given forecast period.

    Global Dental Clinic Cabinet Consumption Market Sample Report 2016 

    Worldwide report on ” Dental Clinic Cabinet Consumption Market” includes a comprehensive study of the Dental Clinic Cabinet Consumption market and defines the key terminologies as well as Dental Clinic Cabinet Consumption market classifications for the benefit of new entrants to the Worldwide Dental Clinic Cabinet Consumption market. This report points out the Dental Clinic Cabinet Consumption Market drivers and restraints affecting the growth of the Dental Clinic Cabinet Consumption market. It also cites the various Dental Clinic Cabinet Consumption Industry opportunities for the Dental Clinic Cabinet Consumption market to grow in the next couple of years.

    The report studies the global Dental Clinic Cabinet Consumption market on the basis of major product types and end user segments. The report related to Dental Clinic Cabinet Consumption Market also compiles data from relevant industry bodies to forecast the growth of each of the segments related Dental Clinic Cabinet Consumption Market Scenario. The report especially focuses on Dental Clinic Cabinet Consumption market and analyzes the various micro- and macro-economic factors affecting the growth of the global Dental Clinic Cabinet Consumption market. Presently, the global Dental Clinic Cabinet Consumption industry economy is witnessing its slowest growth phase in the past two decades related Dental Clinic Cabinet Consumption market scenario.

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    The report profiles some of the key players in the global Dental Clinic Cabinet Consumption market and provides insightful information about Dental Clinic Cabinet Consumption industry, such as business overview, Dental Clinic Cabinet Consumption market product segmentation, revenue segmentation, and latest developments. The report Dental Clinic Cabinet Consumption market analyzes the strengths and weaknesses of the key players through SWOT analysis and projects the Dental Clinic Cabinet Consumption market growth of the key players during the forecast period. The report on ” Worldwide Dental Clinic Cabinet Consumption Industry ” also provides some valuable recommendations and serves as a helpful guide to new as well as existing players in the Dental Clinic Cabinet Consumption market.

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  • Mercury Testing On The Cheap with a Smartphone-based DNA Nanosensor

    Mercury Testing On The Cheap with a Smartphone-based DNA Nanosensor

    mercury test smartphone Mercury Testing On The Cheap with a Smartphone based DNA Nanosensor

     

    Water contaminated with mercury is an all too common reality around the world, while quickly and cheaply detecting the heavy metal remains a challenge. To better test for mercury by just about anyone anywhere researchers ,at UCLA have developed a device that utilizes a smartphone’s camera and processing power to spot mercury ions at concentrations down to about 3.5 parts per million.

    The system requires a mixing  water sample into a  disposable test tube containing a solution of gold nanoparticles and synthesized DNA strands that bind to mercury. The test tube is then positioned into the smartphone attachment where two separate LEDs, one at a wavelength of 523 nm and one at 625 nm, shine light on the mixture and the smartphone camera detects the reflected light signature of the mercury and gold nano particles clustering together.

    The team has done an initial field study of the device , testing over fifty different water sources around California, and believes that screening for mercury using this technology can bring the cost down to around five cents per test.

    More: UCLA team develops rapid smartphone-based mercury testing and mapping…

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  • An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

    An artificial pancreas invented can bring an end to the misery of daily injections for diabetics

    It’s the first device approved by the FDA that detects dropping sugar levels and shuts off regular insulin delivery for Type 1 diabetics, just like a real pancreas is one of  the Best Inventions of the Year 2013 .Too much insulin, which is common at night, can lead to life-threatening diabetic comas.

    An artificial pancreas invented by a De Montfort University (DMU) professor could have its first human trials within two years.

    Professor Joan Taylor’s creation ensures patients will no longer have to endure injections of insulin every day.

    Instead, a device will be surgically implanted into the body and able to release a precise amount of insulin into the bloodstream. Supplies would be topped up every two weeks.

    Human trials are due to begin in 2016 with the first implants taking place on the NHS within a decade – news which has featured prominently in the national press with articles in the Daily Express and the Daily Mail among others.

    Professor of Pharmacy at DMU, Joan Taylor, said: “The device will not only remove the need to manually inject insulin, but will also ensure that perfect doses are administrated each and every time. By controlling blood glucose so effectively, we should be able to help reduce related health problems.

    “We are extremely close to embarking on clinical trials. Diabetes is costing society more than £1million an hour in treatment, and much of that is spent on treating complications.”

    The implant contains a reservoir of insulin kept in place by a special gel barrier. When glucose levels in the body rise, the gel liquefies and releases the insulin into the body, mimicking the normal pancreas.

    As the insulin lowers the glucose levels, the gel reacts by hardening again and preserving the reservoir. It would eliminate the need for diabetics to inject insulin up to four times a day.

    The artificial pancreas will help all Type 1 insulin-dependent diabetics and some suffering Type 2 who need daily injections.

    Professor Taylor has spent 20 years developing the device, which requires no electronics. This means the risk of rejection by the body is minimised.

    Until now, the project has had funding of £1 million from the NHS, the Lachesis Fund – which invests in research in the university – the charity Edith Murphy Foundation and private backers. Professor Taylor is now seeking a similar amount to refine the product.

    “This device is cheap and simple to use,” added Professor Taylor. “It has the potential to bring an end to the misery of daily injections for diabetics.”

    - SOURCE: http://www.dmu.ac.uk/research/research-news/2014/january/human-trials-in-two-years-for-artificial-pancreas-invention.aspx#sthash.42N8lBYF.dpuf

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  • 8K Ultra High Definition Endoscope Offers Unprecedented Video from Our Inside Body

    8K Ultra High Definition Endoscope Offers Unprecedented Video from Our Inside Body

    8k endoscope 8K Ultra High Definition Endoscope Offers Unprecedented Video from Inside Body

    High definition video endoscopes with a resolution in the range of 1080p are still relatively new to the market. They allow for significantly improved visualization of the body’s interior, helping doctors to perform a variety of procedures with confidence. Beyond 1080p HD video is the 4k  standard that’s already showing up on electronic store shelves, but that’s certainly not the end of it. Soon we should see 8K video coming out, which has the resolution equivalent to 16 1080p screens, but in japan there’s already an endoscope capable of transmitting 8K video for a truly unprecendented look inside the body.

    8k endoscope inside 8K Ultra High Definition Endoscope Offers Unprecedented Video from Inside Body

    The technology was made possible by combining a  Hitachi Kokusai Electric 8K camera with an endoscope made by Shinko Optical Co. Because of the substantially improved imaging provided by 8K, the group behind the new system believes that surgeons won’t have to move the camera as much to get  the details in the field of view and be able to see structures not even visible with the naked eye. Moreover, the stereoscopic imaging is improved and the depth of field is increased, allowing for a improved workflow without constantly repositioning the camera…

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