Archive for August 1st, 2012

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Vaccine Research Shows Vigilance Needed Against Evolution of More-Virulent Malaria

Vaccine Research Shows Vigilance Needed Against Evolution of More-Virulent Malaria

Vaccine Research Shows Vigilance Needed Against Evolution of More-Virulent Malaria

ScienceDaily (July 31, 2012) — Malaria parasites evolving in vaccinated laboratory mice become more virulent, according to research at Penn State University. The mice were injected with a critical component of several candidate human malaria vaccines that now are being evaluated in clinical trials. “Our research shows immunization with this particular type of malaria vaccine can create ecological conditions that favor the evolution of parasites that cause more severe disease in unvaccinated mice,” said Andrew Read, Alumni Professor of Biological Sciences at Penn State.

“We are a long way from being able to assess the likelihood of this process occurring in humans, but our research suggests the need for vigilance. It is possible that more-virulent strains of malaria might evolve if a malaria vaccine goes into widespread use,” Read said. The research, which will be published in the 31 July 2012 issue of the scientific journal PLoS Biology, showed that more-virulent malaria parasites evolved in response to vaccination, but the exact mechanism is still a mystery. It was not due to changes in the part of the parasite targeted by the vaccine.

No malaria vaccine ever has been approved for widespread use. “Effective malaria vaccines are notoriously difficult to develop because the malaria parasite is very complex. Hundreds of different malaria strains exist simultaneously within any local region where the disease is prevalent,” Read said. Most vaccine developers use only small sections of the malaria parasite to produce an antigen molecule that then becomes a key ingredient in a highly purified malaria vaccine. Read’s lab tested the antigen AMA-1, a component of several such vaccines now in various stages of clinical trials.

“Our laboratory experiments followed clues from theoretical studies and earlier experiments that suggested that some malaria vaccines could favor the evolution of more-virulent malaria parasites,” Read said. If candidate vaccines do not completely eliminate all the malaria parasites, the parasites that remain have opportunities to evolve. A mosquito then could transfer the evolved parasite from the vaccinated person into a new host — a process called leaking. “Leaky vaccines create a situation that further fosters parasite evolution,” Read said.

The Penn State study found that parasites causing worse malaria symptoms in unvaccinated mice evolved after “leaking” consecutively through as few as 10 vaccinated mice. “The parasites that are able to survive in the immunized hosts must be stronger after having survived exposure to the vaccine,” Read said. “The vaccine-induced immunity apparently removed the less virulent malaria parasites, but left the more virulent ones.”

The AMA-1 antigen used in the Penn State study triggers the body to make anti-malaria antibodies. These antibodies recognize the AMA-1 antigen on the parasites and disable the malaria infection. The shape of the antigen ensures that the antibodies can bind securely with the malaria parasite — like pieces in a jigsaw puzzle — an important step in producing immunity. Scientists already knew that vaccines become obsolete when evolutionary mutations change the parasite’s antigen structure in such a way that the antibody is not able to lock onto the targeted part of the parasite. But the Penn State study showed the malaria parasite evolved within the vaccinated mice even without any detectable changes in the antibody target on the parasite.

“We were surprised to find that more-virulent strains of malaria evolved even while the gene encoding the key antigen remained unchanged,” said Victoria Barclay, the postdoctoral scholar in Read’s lab who conducted the laboratory experiments and who is the corresponding author of the PLoS Biology paper. “We did not detect any changes in the gene sequence.” The researchers conclude that evolution must have taken place somewhere in the parasite’s genome. Read’s lab now is hunting for the exact locations on the parasite’s DNA where the mutations occurred.

“Generalizing from animal models is notoriously difficult in malaria,” Read said, so the scientists do not yet know if this newly recognized type of evolution could happen in human malaria or with other rapidly evolving diseases, such as the viruses that cause AIDS or cervical cancer. “What we do know is that in Victoria Barclay’s experiments in our lab at Penn State; with our parasites, our mice, and with this particular antigen; the malaria parasites that evolved through vaccinated hosts become more virulent,” he said.

“Vaccines are one of the most fantastically cost-effective health gains we’ve ever had, so there is no question that we should proceed on all fronts to develop a safe and effective vaccine against malaria,” Read said. “At the same time, our research is revealing new reasons to proceed with vigilant caution.” Read suggests that vaccine researchers conducting clinical trials should not only be carefully monitoring for parasite evolution at the vaccine target, but they also should watch for mutations throughout the parasite’s entire genome. “This sort of monitoring also should go on once a new vaccine goes into widespread use,” he said. “It appears that in a world with leaky vaccines, virulent pathogen strains can evolve. Different vaccines or other transmission-blocking measures might be needed to stop the spread of any evolved parasites,” Read said.

source : http://www.sciencedaily.com/releases/2012/07/120731200620.htm

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Clemson Knee Simulator to Help Improve Unicompartmental Knee Arthroplasty

Clemson Knee Simulator to Help Improve Unicompartmental Knee Arthroplasty

Clemson Knee Simulator to Help Improve Unicompartmental Knee Arthroplasty

Unicompartmental knee arthroplasty (UKA) is a surgical procedure used to treat osteoarthritis when the damage is only limited to one compartment of the knee. The main advantages of this procedure over the total knee replacement (TKR) include preservation of bone stock, more physiologic joint movement, improved proprioception, increased range of motion (ROM), and faster recovery time.

Despite its reported success rates, (87 to 98% survivorship at ten years) UKA has not gained universal recognition as the appropriate procedure of arthritis of a single condyle. This is mainly due to its more complex procedure and a reported slightly lower success rates compared to TKA.

Progression of arthritis in the non-operated compartment, polyethylene wear, aseptic loosening, fracture, and revision due to pain are some of the reported failure modes of UKA. These failure modes are believed to be associated with poor implant design, patient selection, and alignment during surgery, and a mismatch in compliance between soft tissues and implant material. All these could result in abnormal loading distributions on the knee, which are thought to accelerate degradation and lead to increased rates of clinical failure.

Our research focuses on investigating the effects of different UKA alignment and ligament configurations on the movement and contact pressure distributions on the knee. The knowledge obtained from the current and future studies performed using the rig may help physicians and researchers to improve implant designs, surgical techniques, patient selection criteria, or better inform the patient about possible post-operative or rehabilitation risks.

Due to measurement limitations on the patient study, we have designed and constructed Clemson knee simulator in which cadaveric specimens can be mounted for the study. The cadaveric specimens will be obtained in collaboration with our clinical partners from the Greenville Hospital System (GHS), Grenville, SC. The rig has the advantages of being a reasonable simulation of the entire lower extremity in activities such as rising from a seated or crouching position while allowing measurements of internal loadings (contact pressures), which could not be performed accurately in a living patient. We are utilizing a motion tracking system that allows 3-D position tracking of the knee movement during simulation. The contact pressure and area of the articulating surfaces are measured using paper-thin film pressure sensors which can be inserted in between the knee joint.

We are currently working on validating the simulator to ensure its ability to capture the key motion characteristics of a normal knee with artificial bones and implant. The funding that we have recently received from OREF (Orthopaedic Research & Education Foundation) in collaboration with our clinical partners will be used to obtain cadaveric specimens needed to perform the stated UKA study. The results from the experiment will be analyzed and used to better understand the underlying causes of UKA failures, which will eventually lead to improvement in implant designs, surgical techniques, patient selection criteria and etc.

Research to improve knee implant design, surgical techniques, and patient selection criteria is taking place at the Frank H. Stelling and C. Dayton Riddle Orthopaedic Education and Research Laboratory located on the Clemson University Biomedical Engineering Innovation Campus (CUBEInC).

Roy Junius Rusly is a PhD student, teaching assistant, and research assistant at Clemson University’s College of Engineering and Science. Rusly’s PhD advisor is John D. DesJardins, assistant professor and director of Bioengineering Abroad Programs in the Department of Bioengineering.

For media inquiries, please contact Brian Mullen at mullen2@clemson.edu or 864-656-2063.

Researchers at Clemson University in South Carolina created a special human knee simulator that they hope will help improve various aspects of unicompartmental knee arthroplasty (UKA). Because every patient’s knee is unique, including how it is affected by arthritis over time, the success of surgery can vary greatly. Additionally, proper matching of implants to patients remains a hit-and-miss process that has the potential for a lot of improvement.

The new simulator provides a platform for testing various aspects of UKA using cadaveric knee specimens. The team hopes to test a great deal of alignment and ligament configurations and how they affect the movement and pressures within the knee. The hope is that this research will make UKA safer and more effective, making it a more commonly accepted procedure that is currently looked upon with a bit of skepticism from the orthopedic community.

Some details from the research team:

The rig has the advantages of being a reasonable simulation of the entire lower extremity in activities such as rising from a seated or crouching position while allowing measurements of internal loadings (contact pressures), which could not be performed accurately in a living patient. We are utilizing a motion tracking system that allows 3-D position tracking of the knee movement during simulation. The contact pressure and area of the articulating surfaces are measured using paper-thin film pressure sensors which can be inserted in between the knee joint.

We are currently working on validating the simulator to ensure its ability to capture the key motion characteristics of a normal knee with artificial bones and implant. The funding that we have recently received from OREF (Orthopaedic Research & Education Foundation) in collaboration with our clinical partners will be used to obtain cadaveric specimens needed to perform the stated UKA study. The results from the experiment will be analyzed and used to better understand the underlying causes of UKA failures, which will eventually lead to improvement in implant designs, surgical techniques, patient selection criteria and etc.

Source : http://blogs.clemson.edu/discovery/2012/07/26/

www.exploring-ways-to-improve-knee-implant-design-surgical-techniques-and-patient-selection-criteria/

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Covidien’s Nellcor Bedside SpO2 Patient Monitoring System

Covidien’s Nellcor Bedside SpO2 Patient Monitoring System

Covidien’s Nellcor Bedside SpO2 Patient Monitoring System

BOULDER, Colo.–(BUSINESS WIRE)–Jul. 30, 2012– Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care solutions, today announced the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance to market the Covidien Nellcor™ Bedside SpO2 Patient Monitoring System. The new patient monitoring system is now available for sale in the U.S.

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (P …

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (Photo: Business Wire)

The Nellcor Bedside SpO2 system with OxiMax™ technology continuously monitors SpO2 and pulse rate for adult, pediatric and neonatal patients, giving clinicians instant access to comprehensive trending respiratory information. This enables clinicians to detect subtle, yet critical, heart rate and SpO2 variations earlier and thus address respiratory complications sooner.

“We are pleased to announce the new Covidien Nellcor Bedside SpO2 Patient Monitoring System is approved for commercial release in the United States,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “Healthcare professionals on the general care floor, and in other lower- acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats. By giving them ready access to a patient’s respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data.”

The Nellcor Bedside SpO2 Patient Monitoring System also features enhanced digital signal processing for precise SpO2 readings during low perfusion or other challenging conditions that make it difficult to accurately track these patients. Its SatSeconds™ alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms. The monitor further offers an intuitive, multicolor screen that is easy to read in any light and from many angles. Additionally, hospital technicians can set institutional defaults, replace the battery, perform diagnostics and generally maintain the monitor within the hospital, saving time and resources.

The Nellcor Bedside SpO2 Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, and complies with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) directive for products sold in European Economic Area markets.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.covidien.com&esheet=50357234&lan=en-US&anchor=www.covidien.com&index=2&md5=d6045bce4a0772738020896216e753f4 to learn more about our business.

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Coviden has been busy lately. In the last month or so, we’ve covered three pieces of news related to the Irish medical device company, including its OneShot renal denervation system, Endo GIA radial reload colon cutter/stapler and V-Loc knotless suturing technology.

Now, the company has announced the debut of the Nellcor SpO2 single parameter module for use with the Philips IntelliVue line of patient monitoring systems, including the MP40 through MP90 products and the MX 600, MX 700, and MX 800 monitors.

The module will be available in North America, Europe, and a number of other international markets. It uses the firm’s OxiMax pulse oximetry technology to monitor a patient’s respiratory function status.

Robert J. White, Coviden’s president of respiratory and monitoring solutions explains in a press release that the product’s broad compatibility enables it to be used “across all areas of the hospital, from the general care ward to critical care areas, such as the intensive care unit and neonatal care ward.”

The use of the pulse oximetry device with monitoring platforms provides clinicians with cardiac-based readings of SpO2 and pulse rate. This functionality supports its use in what the company’s chief medical officer, Scott Kelley, MD, describes as “challenging conditions” such as low perfusion.

The Nellcor OxiMax technology includes an alarm management feature to help clinicians distinguish between minor events and clinically significant fluctuations in desaturation.

Features according to Covidien:

Simple, intuitive operation and space-saving design.

The distinctive digital signal processing technology from Covidien.

Variable pitch beep tone which enables clinicians to hear point-by-point changes in SpO2.

Five-hour battery life with an optional ten-hour battery.

96-hour trend memory captured every four seconds.

Patient trend data can be stored on a PC for archive and analysis.

Easy-to-use jog dial for simple navigation and control of the display and monitoring system functions.

Compact, portable, lightweight, durable, easy-to-transport design with a built-in handle.

Multiple-language graphical user interface.

Capable of displaying plethysmographic waveforms, pulse amplitude, and current measured SpO2 and pulse rate.

Multicolor display screen with a black background which provides ideal contrast.

Back-up audible alarm.

On-screen help messages to assist the user in the use of the monitor.

Source : http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&id=1719745

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C-Pulse Extra-Aortic Heart Pump Wins Approvals in Europe

C-Pulse Extra-Aortic Heart Pump Wins Approvals in Europe

C-Pulse Extra-Aortic Heart Pump Wins Approvals in Europe

Sunshine Heart Announces CE Mark for C-Pulse® Heart Assist System

EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA–(Marketwire – Jul 25, 2012) – Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced today that it has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure. This will allow for commercialization of the technology in Europe and countries in Asia and Latin America that recognize the CE Mark. The Class III heart failure population is estimated at 3.7 million patients in the European Union, and currently, there are limited, and often, unsuccessful treatment options for this patient population.

“We are proud to have achieved another significant milestone in the Company’s history. The CE Mark approval includes our second generation driver, cuff and other components which we believe will improve the overall device performance and ultimately patients’ quality of life,” said Dave Rosa, Chief Executive Officer of Sunshine Heart.

We expect to complete our second generation driver evaluation in Canada by the end of the third quarter 2012. Soon afterwards, we plan to take a targeted approach to initiate select centers in Europe to participate in a post market clinical trial that we expect will generate data for reimbursement coverage and to provide additional confirmation of performance.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, an investigational device, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient’s bloodstream, the extra-aortic approach of the C-Pulse technology offers greater flexibility, allowing patients to safely disconnect to have intervals of freedom to perform certain activities such as showering. The C-Pulse System may help maintain the patient’s current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

About Sunshine® Heart

Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) is an early-stage global medical device company committed to the commercialization of the C-Pulse Heart Assist System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure. The C-Pulse System can be implanted using a minimally invasive procedure and is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology, which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart’s pumping load. We have completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified us that we can move forward with an investigational device exemption (IDE) application. We expect to submit an IDE application to the FDA in the second half of 2012 for approval to initiate our pivotal trial. In July 2012 we received CE Mark for our C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004 and on NASDAQ beginning February 2012. For more information, please visit www.sunshineheart.com.

Forward-Looking Statements

Certain statements in this report are forward-looking statements that are based on management’s beliefs, assumptions and expectations and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations with respect to product development and commercialization efforts including within the EU, Latin America and Asia, results of driver evaluation and clinical trials, timing of regulatory filings and approvals, regulatory acceptance of our filings, research and development activities, ultimate clinical outcomes and benefits of our products to patients, market and physician acceptance of the products, intellectual property protection, and potentially competitive product offerings. These forward-looking statements are subject to numerous risks and uncertainties, including without limitation, the possibility that our clinical trials do not meet their end-points or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse Heart System, the possibility we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption “Risk Factors” and elsewhere in our filings with the U.S. Securities and Exchange Commission (SEC) and ASX. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

C-Pulse

The C-Pulse Heart assist system is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure. These symptoms normally include shortness of breath, dizziness, low blood pressure and fluid retention. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life. The C-Pulse Heart Assist System may be implanted through a minimally invasive or full sternotomy technique.

The C-Pulse System’s design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, the workload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient’s ECG, similar to a pacemaker. Potential benefits of the technology, which are currently being analyzed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac function.

The C-Pulse is designed to improve heart function in three ways:

1

More blood flow from the heart called increased cardiac output

2

More oxygen to the heart muscle, called increased coronary blood flow

3

Less work for the heart, called decreased afterload

Heart fills with blood then cuff inflatesHeart pumps as the cuff deflates

The C-Pulse System may be implanted via a small pacemaker like incision through the ribs (mini-thoracotomy) and sternum (mini-sternotomy) or through a traditional full sternotomy. The anticipated stay in the hospital may be between 4-14 days. Several patients currently enrolled in the Company’s FDA approved IDE feasibility trial have been able to return home in as little as four days when the procedure has been performed minimally invasively.

The implant part of the procedure is typically performed in an hour. The cuff portion of the C-Pulse Device is placed around the ascending aorta, and outside the patient’s bloodstream. Because of this, the risk of stroke and blood clots is potentially reduced. There is also no need for patients to take anti-clotting medications such as heparin or warfarin while implanted unless other medical conditions require this. Because of these features, the procedural and device patient risks may be lower when compared to other currently approved Class III/IV mechanical circulatory assist technologies.

The C-Pulse can be temporarily disconnected. Patients have expressed satisfaction in being able to shower, take a walk and perform other activities independent from the system.

Sunshine Heart of Eden Prairie, MN received European clearance for its C-Pulse cardiac assist device for use in patients with Class III and ambulatory Class IV heart failure. C pulse heart C Pulse Extra Aortic Heart Pump Wins Approvals in EuropeThe pump is uniquely designed to wrap around the ascending aorta and help the left ventricle do its work without directly coming in contact with the pumped blood. Beside the clinical benefits of this approach, such as potentially reduced chances of blood clotting, the extra-aortic counter-pulsation technology allows patients to temporarily turn off and disconnect the system from the power supply as needed for bathing and other tasks.

According to the company, “The C-Pulse System may help maintain the patient’s current condition and, in some cases, reverse the heart failure process, thereby potentially preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.”

Sunshine Heart is also actively navigating the FDA’s approval process and is expecting to initiate a pivotal trial in the coming months:

We have completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified us that we can move forward with an investigational device exemption (IDE) application. We expect to submit an IDE application to the FDA in the second half of 2012 for approval to initiate our pivotal trial.

http://www.youtube.com/watch?v=IBE6EDTiULA&feature=player_embedded

source : http://www.marketwire.com/press-release/

www.sunshine-heart-announces-ce-mark-for-c-pulser-heart-assist-system-nasdaq-ssh-1683508.htm

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Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

Proteus Digital Health Announces FDA Clearance of Ingestible Sensor

REDWOOD CITY, Calif. – July 30, 2012 – Proteus Digital Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its ingestible sensor for marketing as a medical device. The ingestible sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients’ health habits and connections to caregivers.

Proteus has worked collaboratively with the FDA since 2008 to determine the regulatory pathway for this innovation, which represents a new category of medical device and patient care. The application was ultimately processed in accordance with the de novo provisions of the Federal Food, Drug and Cosmetic Act for low-risk devices that have no predicate on the market.

“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” said Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health. “We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings.”

“The FDA validation represents a major milestone in digital medicine. Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management,” said Dr. Eric Topol, professor of genomics at The Scripps Research Institute and author of “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare”.

The Proteus ingestible sensor can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position and activity. The patch relays information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

About Proteus Digital Health

Proteus Digital Health, Inc. is developing and commercializing digital health feedback technology that is integrated into ingestible products. This provides an unprecedented view into an individual’s personal health choices and physiologic response, allowing patients to better manage their health and more effectively collaborate with caregivers and clinicians, while enabling new information-based business models. Proteus received a CE mark in August 2010 and U.S. FDA approval in July 2012 for its technology platform. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic,

Proteus Biomedical has received CE Mark approval from the European Union to bring to market the firm’s Raisin ingestible drug sensors and monitoring system. baquh04l Proteus Pill Ingestion Monitoring System Gets EU Green LightWhen a patient swallows tablets that have individually tagged beacons on them, a sensor can automatically record the precise time and basic vital signs of the patient at that time. The system allows physicians to get a better picture of how a patient responds to a given medication. The system received FDA regulatory approval back in April. Additionally MobiHealthNews is reporting that UK’s National Health Service will be testing the system in a trial involving 40 patients over four months.

Proteus’s ingestible sensor and personal monitor system, called the RaisinTM System, is indicated under the CE Mark to timestamp, via ingestion, any discrete event (such as the ingestion of a specific pharmaceutical) and to record this event along with physiologic information such as heart rate, activity, body angle and patient-logged information. The unique ingestion event and personalized physiologic information are then communicated via Bluetooth to any computerized device, such as a mobile phone for emerging mHealth applications.

The Raisin System is being developed as part of Proteus’s integrated intelligent medicine system to link sensor-based formulations of pharmaceutical products to individualized physiologic response and outcomes-based treatment systems. Proteus and its partners are currently developing these integrated product systems in diabetes, cardiovascular disease, psychiatric disorders, organ transplantation and infectious disease.

Proteus Digital Health has received FDA clearance for its ingestible sensor. The sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, which also includes a wireless skin patch (previously called Raisin Personal Monitor) with which the sensor communicates. The sensor can be integrated into ingested products such as pharmaceuticals, to track when one actually swallows one of these substances.

The sensor measures 1mm square and is made mostly of silicon. It does not contain a battery, but is powered for a short amount of time by contact of two conductive materials with stomach acid. It sends a signal to the skin patch at the moment it reaches the stomach allowing the patch to record the exact time medication is taken, as well as the unique identity of that medication.

Besides communicating with the ingestible sensor, the patch records heart rate, temperature, activity and rest patterns. The patch is battery-operated and lasts approximately seven days, after which it must be replaced.

The Proteus ingestible sensor can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position and activity. The patch relays information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

Source : http://proteusdigitalhealth.com/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor/

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FDA Grants IDE Nod to Innovative High Blood Pressure Device

FDA Grants IDE Nod to Innovative High Blood Pressure Device

FDA Grants IDE Nod to Innovative High Blood Pressure Device

BOISE– 1/18/2012 – Zona Health, developer of non-invasive, non-drug treatments for hypertension, announced that the U.S. Food and Drug Administration (FDA) conditionally approved an Investigational Device Exemption (IDE) for a pivotal clinical trial to evaluate the Company’s patented isometric handgrip therapy technology (ZonaRx™) for use in the treatment of resistant hypertension (high blood pressure in the presence of two or more medications), an especially dangerous disease affecting hundreds of millions of people worldwide. FDA approval of the IDE makes Zona Health’s study the first pivotal trial of isometric handgrip therapy for hypertension treatment.

The investigatory team for the study includes JoAnn Lindenfeld, M.D., Director of the Cardiac Transplant Program at University Hospital in Aurora, Colorado, and a member of the FDA Devices Committee; Suzanne Oparil, M.D., Professor of Medicine and Director of the Vascular Biology and Hypertension Program in the Division of Cardiovascular Disease at the University of Alabama at Birmingham, and Co-chair of The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8); and Kenneth Kronhaus, M.D., Ph.D., Cardiologist, and American Heart Association Spokesman.

“We are very pleased with the IDE approval and look forward to commencing the pivotal study to provide longer term safety and efficacy data of our ZonaRx™ hypertension treatment technology in this set of resistant hypertensive patients,” said Steven Wood, President and CEO of Zona Health. “We believe this innovative treatment has the potential to provide patients with an effective way to control their blood pressure when other treatment options are insufficient.”

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Clinical research shows that Zona Health’s isometric handgrip therapy may provide a significant reduction in blood pressure levels for the majority of hypertensive patients. Across several earlier studies, 135 out of 136 participants achieved significant blood pressure drops in eight weeks or less.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. High blood pressure is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of modern antihypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.

About Zona Health

Zona Health is a privately held medical device company headquartered in Boise, Idaho. The Company’s proprietary technology is designed for effective, non-drug and non-invasive treatment of hypertension. Zona Health currently manufactures and markets the Zona Plus™, a medical device for the improvement of overall cardiovascular health. Additional information can be found at www.zona.com.

The FDA has conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate a new patented isometric handgrip therapy technology. A product of Zona Health (Boise, ID), the ZonaRx device was developed for use in the treatment of resistant hypertension (high blood pressure that persists despite treatment by two or more medications). The IDE approval marks the first pivotal trial of isometric handgrip therapy for hypertension treatment.

Earlier clinical studies demonstrate that the isometric handgrip therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive patients,” according to Zona Health. According to earlier data, 135 out of 136 study participants achieved significant blood pressure drops in eight weeks or less.

From the announcement:

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Source : http://www.qmed.com/news/fda-grants-zona-health-ide-approval-innovative-study-high-blood-pressure

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DuoFertility Ovulation Monitor Receives FDA Approval

DuoFertility Ovulation Monitor Receives FDA Approval

DuoFertility Ovulation Monitor Receives FDA Approval

A UK company called Cambridge Temperature Concepts is offering a refinement to traditional temperature measurements. Their new device, the DuoFertility, reads data from a patch that lives in a woman’s armpit, to explain ovulation patterns.

Currently the device is in a trial period, although the employees of Cambridge Temperature Concepts say it’s been working great on them (though that disclosure raises many more questions than it answers).

And, just as with any prototype, there are gaffes to make even the novice marketer blush, such as this one comparing their device to traditional thermometers:

There is no need to wake up at 6am each morning to take your temperature. You are free to spend the first 5 minutes of your day as you wish!

Five minutes of free time per day? What a great machine!

And, if you’re curious, those strange button symbols along the edges are supposed to help classify the temperature data. The buttons on the left, for instance, signify (from top to bottom) “period starting”, “made love”, “feeling ill” and “sleep disruption” … if you press the buttons in the right sequence you can not only predict fertility, but pretty much describe all your college relationships.

Via Engadget (which took a break from iPhone coverage to bring you this, but only because it has an iPod-style clickwheel)

All the help and support you need to get pregnant – naturally

Is DuoFertility for me?

~ Suitability Tool ~

DuoFertility is a fertility monitoring service with expert support, and a pregnancy rate like IVF at a fraction of the cost. We help you get pregnant naturally, and avoid invasive medical procedures such as in-vitro fertilisation (IVF). Simply place the small patch under your arm, connect to the online service every few days, and receive expert help and support every step of the way.

DuoFertility is convenient, totally natural, non-invasive and drug free.

DuoFertility predicts your fertile days, confirms ovulation, and gives you personal expert support.

Every day DuoFertility helps hundreds of couples just like you.

The only product with the reassurance of a pregnancy guarantee :

pregnant in 12 months – or your money back.

At the Future Health Mission 2011 in San Francisco last week, we were offered a chance to check out some of the latest and most promising medtech startups from the United Kingdom, who came for a tour of Silicon Valley.

Here’s one technology that impressed us a lot. DuoFertility is an ovulation pattern temperature monitor from Cambridge Temperature Concepts Ltd. The DuoFertility technology was profiled by us back in 2008 when it was in prototype stage. Now it is a fully developed device that has an auxiliary temperature monitoring patch and a receptacle that downloads temperature data from the patch and sends it to a service center. The idea is to use the temperature variations of a woman to extrapolate the best day(s) for her to conceive. According to the company’s CEO and founder Dr Shamus Husheer, the device is already selling quite well in emergent markets such as Middle East and Asia, and is on its way to wider use in Europe. And, of course, the company is hoping to obtain US FDA approval sometime in the near future. Here’s Dr Husheer answering our questions about the technology and the future of the company:

More from the product page:

The system is based on a sophisticated version of the body basal temperature (BBT?) measurement method (the small upward shift in basal body temperature which is associated with ovulation). The system identifies when you are most likely to get pregnant, up to six days in advance. This gives you plenty of time to plan intercourse for the best time of the month.

Temperature measurements are made automatically up to 20,000 times per day by the DuoFertility sensor. In addition, personal fertility related data you provide such as menstruation? dates, ovulation pain, etc are also added into the fertility analysis to give you the most accurate predictions possible.

Source : http://www.duofertility.com/

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Planmed Verity Mobile Extremity CT Scanner for Orthopedic Imaging Receives CE Mark

Planmed Verity Mobile Extremity CT Scanner for Orthopedic Imaging Receives CE Mark

Planmed Verity Mobile Extremity CT Scanner for Orthopedic Imaging Receives CE Mark

Planmed Verity, a new, mobile extremity scanner for orthopedic imaging of the extremities receives the CE mark and thus, is now available for sale in the EU and many other countries where the CE certificate permits sales.

Planmed Verity Extremity Scanner utilizes cone-beam CT (CBCT) technology that provides fast and accurate low-dose 3D imaging of peripheral skeletal fractures and disorders at the point-of-care. The compact, mobile device can be easily sited in any existing X-ray room, side-by-side with other imaging systems.

“As an all new approach to imaging of extremities, the Planmed Verity system has already raised a lot of interest within the field of orthopedic imaging. Now the pending system deliveries can begin”, says Mr. Vesa Mattila, Vice President of Planmed Oy.

Planmed’s innovation provides volumetric 3D imaging for accurate and fast diagnosis with a substantially lower radiation dose compared to conventional CT imaging. During the scan, which takes less than 20 seconds, images are acquired using a short X-ray pulse instead of continuous radiation. This enables a low radiation dose.

For optimum patient comfort the Planmed Verity features an adaptable, soft-surfaced gantry with a TearDrop™ -shaped bore optimized for orthopedic imaging. The gantry and positioning trays are easily adjustable for imaging for example a foot, ankle, knee, hand, wrist, or elbow. Furthermore, special gantry movements allow weight-bearing 3D scans of a standing patient, a new way of extremity imaging which has not been possible with conventional CT scanners.

Planmed Verity® utilizes CBCT (Cone Beam Computed Tomography) technology to provide high resolution volumetric (3D) images of the extremities at a particularly low dose. Compact, stand-alone and mobile Planmed Verity can fit into almost any existing X-ray room and can be easily sited even side by side with other imaging equipment. With adjustable, soft surfaced gantry and dedicated patient positioning trays Planmed Verity provides versatile patient positioning and optimized patient comfort.

Planmed Verity is a trademark of Planmed Oy.

3D Orthopedic Imaging at Low Dose

Based on Cone Beam Computed Tomography technology

Volumetric imaging with multi-planar reconstruction and volume rendering provide optimal visualization of fractures and deformations

Superior isotropic resolution of up to 0.2mm (optional 0.1mm high resolution mode)

Dose up to ten times lower compared to extremity imaging protocols with conventional MDCT (Multi Detector Computed Tomography)

Planmed (Helsinki, Finland) has received European CE Mark for the Planmed Verity, a mobile extremity CT scanner for orthopedic imaging. planmed verity standing Planmed Verity Mobile Extremity CT Scanner for Orthopedic Imaging Receives CE MarkThe Planmed Verity Extremity Scanner utilizes cone-beam CT (CBCT) technology that provides fast and accurate low-dose 3D imaging of peripheral skeletal fractures and disorders at the point-of-care. Volumetric imaging with multi-planar reconstruction and volume rendering can be performed with an isotropic resolution of up to 0.2mm (optional 0.1mm high resolution mode).

Scanning takes less than 20 seconds during which images are acquired using a short X-ray pulse instead of continuous radiation, resulting in a radiation dose of up to ten times lower compared to extremity imaging protocols with conventional CT. The compact, mobile device can be sited in any existing X-ray room, side-by-side with other imaging systems.

The gantry and positioning trays are adjustable for imaging the foot, ankle, knee, hand, wrist or elbow. Special gantry movements allow weight-bearing 3D scans of a standing patient, which is not possible with conventional CT scanners. The adjustable gantry position also allows for imaging of wheel-chair patients as well as bed-side imaging.

source : http://www.planmed.com/index.php?lng=1&page=00021&news_id=133

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Nike Releases NIKE+ FuelBand Activity Monitor

Nike Releases NIKE+ FuelBand Activity Monitor

Nike Releases NIKE+ FuelBand Activity Monitor

Nike+ FuelBand tracks your activity through a sport-tested accelerometer. Then translates every move into NikeFuel. Nike+ FuelBand tracks running, walking, dancing, basketball – and dozens of everyday actions. It also syncs up with a motivational web and mobile experience. So put it on and get moving.

WHAT IS NIKEFUEL?B

It starts with a goal

How active do you want to be? Set your Daily Goal and Nike+ FuelBand tracks your progress, lighting up from red to green throughout the day. Get to green and you’ve hit your goal.

Make life a sport

Turn every day into a game. Challenge yourself to capture records, reach new milestones, and unlock special achievements. Go on a streak by seeing how many days in a row you can hit your daily goal.

Track your progress

Sync your Nike+ FuelBand every day to visualize your results. See your peaks, your valleys, and your progress.

Tour the Experience

Mobile Tour

Web Tour

NEW YORK–(BUSINESS WIRE)–NIKE, Inc. (NYSE:NKE) announced today the NIKE+ FuelBand, an innovative wristband that tracks and measures everyday movement to motivate and inspire people to be more active. Activities can now be measured through a new metric called NikeFuel: the more active you are, the more NikeFuel you earn.

“You don’t have to be an elite athlete to appreciate how NikeFuel can motivate you. It’s an easy way to get credit for activities and compare how you do with others, even if you take part in different sports.”

NIKE, Inc. President & CEO Mark Parker unveiled NIKE+ FuelBand at an event in New York attended by seven-time Tour de France champion Lance Armstrong, Oklahoma City scoring champion and all-star Kevin Durant and 2011 IAAF women’s 100-meter World Champion Carmelita Jeter.

“The NIKE+ FuelBand is a way for Nike to further evolve the exciting possibilities of merging the physical and digital worlds,” said Parker. “Nike has always been about inspiring athletes, and the NIKE+ FuelBand will help motivate them in a simple, fun and intuitive way.”

Designed to be worn throughout the day, the ergonomic, user-friendly NIKE+ FuelBand uses accelerometry to provide information about different activities through movement of the wrist via a LED dot matrix display. Four metrics are available: Time, Calories, Steps and NikeFuel. Unlike calorie counts, which vary based on someone’s gender and body type, NikeFuel is a normalized score that awards equal points for the same activity regardless of physical makeup.

Users set a daily goal of how active they want to be, and how much NikeFuel they want to achieve. The NIKE+ FuelBand displays a series of 20 LED lights that go from red-to-green as the user gets closer to their goal. The FuelBand syncs with the Nike+ website through a built-in USB, or wirelessly through Bluetooth to a free iPhone app, to record activity and track progress every day. The app interface also provides encouragement and motivation as goals are achieved.

Armstrong said, “What’s great about the idea of NikeFuel and the FuelBand is the way it provides real information and numbers to show how much people are doing all day, every day. That’s what will get people challenging themselves to do more and better their own scores. It’s a tool to get people more active.”

“NikeFuel means everyone can get recognition for activities they do,” said Durant. “It provides a scoreboard for your day and gets everyone moving.”

Jeter said, “You don’t have to be an elite athlete to appreciate how NikeFuel can motivate you. It’s an easy way to get credit for activities and compare how you do with others, even if you take part in different sports.

The Nike+ Fuelband will be available for preorder starting January 19th in the US at Nikestore.com for a suggested retail price of $149 (US).

To use Nike+ FuelBand, the following is needed:

A Macintosh or PC with built-in USB. Mac OS v 10.4 or later, Windows 7 or Windows Vista (SP2) or Windows XP (SP2)

Internet access. Broadband is recommended.

Optional mobile app available in the iTunes App store; for updates on compatible mobile devices, visit Nikeplus.com

About NIKE, Inc.

NIKE, Inc., based near Beaverton, Oregon, is the world’s leading designer, marketer and distributor of authentic athletic footwear, apparel, equipment and accessories for a wide variety of sports and fitness activities. Wholly owned Nike subsidiaries include Converse Inc., which designs, markets and distributes athletic footwear, apparel and accessories; Cole Haan, which designs, markets and distributes luxury shoes, handbags, accessories and coats; Umbro Ltd., a leading United Kingdom-based global football (soccer) brand; and Hurley International LLC, which designs, markets and distributes action sports and youth lifestyle footwear, apparel and accessories. For more information, visit www.nikeinc.com and follow @Nike.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50138665&lang=en

Go mobile

Get the free Nike+ FuelBand mobile app to sync wirelessly, track your progress, and get extra motivation on the go. With the app you can compete with yourself, or share results with your friends to compare, compete and celebrate.

Personalize your day

How does your mood impact your performance? Choose an emotion, add a personal note, and keep track.

See your progress

Find out how you did this week, month and beyond. The app breaks your activity down and graphs it up, so you can make sense of it from a glance.

Keep it going

Nail your Daily Goal a few days in a row and you’re on a streak. See how long you can keep it going.

Tell the world

Hit your goals. Break your personal records and share it all on Facebook and Twitter.

Get more with NikePlus.com

Nike+ FuelBand plugs in through your USB and syncs with the Nike+ website, so you can track your progress, compare with the Nike+ community, and get movitation to do more.

Set a Daily Goal

What moves you? Set a Daily Goal. Hit it day after day and go on a streak. Want to think bigger? Create and conquer larger milestones.

Take it further

Nike+ helps you along the way, suggesting Next Moves. Just for you.

See your day

Visualize your daily activity to see when you’re most active – and when you’re not.

Personalize your day

How were you feeling? Keep notes and keep track.

Review your history

Get daily, weekly and monthly views of your activity and learn more about yourself than you ever knew before.

Stay motivated

Nike+ is here to cheer you on with rewards and surprises along the way.

Share your successes

Collect your trophies and achievements and share them on Facebook and Twitter. You did it. Go ahead and flaunt it.

Get the Software

If you already have a Nike+ FuelBand, get started by downloading the Nike+ Connect software. This software allows your Nike+ FuelBand and computer to communicate with each other. It also lets you customize your Nike+ FuelBand settings.

DOWNLOAD NIKE+ CONNECT

Nike+ Connect Software Update 5.1.0

The Nike+ Connect software that runs on your computer has been improved. This update is required for all Nike+ device users and includes the following changes:

Correctly displays text in some non-English languages

Updated dialog communication

Supports updated functionality of the Nike+ FuelBand and Nike+ Sport Sensors

Additional bug fixes

Tech Specs

Sizes

Small 5.79 in (147 mm) circumference

Medium 6.77 in (172 mm) circumference

Large 7.76 in (197 mm) circumference

Depth 0.6 in (16 mm) at LEDs, 0.75 in (19 mm) at latch Thickness: 0.27 in (6.90 mm) at LEDs, 0.32 in (8.00 mm) at latch

Nike+ FuelBand comes with two easy to insert links so you can fine tune your fit: 0.32 in (8 mm) and 0.63 in (16 mm)

What size is right for you?

Find out with our sizing guideB

Weight

Small 0.95 oz (27 g)

Medium 1.06 oz (30 g)

Large 1.13 oz (32 g)

8 mm link 0.07 oz (2 g)

16 mm link 0.11 oz (3 g)

Sensors

A built-in 3 axis accelerometer measures your motion all day long.

An ambient light sensor detects environmental light levels. The brighter your environment, the brighter your display.

Display

20 Color LED lights

show your Daily Goal progress from red to green.

Array of 100 white LED lights

shows time, NikeFuel earned, calories burned, and steps taken. You can cycle through all this with the push of a button.

The brightness level automatically adjusts according to your environment.

100 white LEDs

20 Color LEDs

Button

Water Resistance

The Nike+ FuelBand is water resistant. It is safe to wear in the shower or when dancing in the rain. Since it’s not waterproof, it’s not recommended for use while swimming.

Connect and Sync

Connect to your computer with the built-in USB 2.0 or use the included USB cable and stand.

Bluetooth pairing to mobile phones for use with the Nike+ FuelBand app for iOS 5. Check back soon for compatibility with other handsets.

Airplane Mode for disabling radio connections.

Battery

Two Lithium Polymer Batteries. Your Nike+ FuelBand should stay charged for up to four days.

In the Box

Nike+ FuelBand

8mm and 16mm links (8mm link is already inserted into your Nike+ FuelBand)

Sizing tool

USB charging cable

USB stand

Materials

TPE 43%, Polypropylene 34%, Magnesium 14%, Stainless Steel 9%

PVC free

Package is 100% recyclable paper.

More Ways To Track

Nike+ SportWatch GPSB

Powered by TomTom

GPS tracking, takes splits, reminds you to run–even remembers all your PRs.

Nike+ SportBandB

An easy-to-use device with a customizable display, so you see whatever info is most important to you.

Nike+ Running AppB

Download this to map and track your outdoor runs. No sensor required.

Nike has released its own digital wristband for monitoring physical activity throughout the day.nike fuel Nike Releases NIKE+ FuelBand Activity Monitor

The device provides readouts right on its face, but can also wirelessly transmit gathered data to an iPhone app or a computer via a built-in USB plug. Users can then do a more comprehensive review of what they’ve been up to and can adjust their activities accordingly.

From the announcement:

Designed to be worn throughout the day, the ergonomic, user-friendly NIKE+ FuelBand uses accelerometry to provide information about different activities through movement of the wrist via a LED dot matrix display. Four metrics are available: Time, Calories, Steps and NikeFuel. Unlike calorie counts, which vary based on someone’s gender and body type, NikeFuel is a normalized score that awards equal points for the same activity regardless of physical makeup.

Users set a daily goal of how active they want to be, and how much NikeFuel they want to achieve. The NIKE+ FuelBand displays a series of 20 LED lights that go from red-to-green as the user gets closer to their goal. The FuelBand syncs with the Nike+ website through a built-in USB, or wirelessly through Bluetooth to a free iPhone app, to record activity and track progress every day. The app interface also provides encouragement and motivation as goals are achieved.

Source : http://www.businesswire.com/news/home/20120119005968/en/

www.NIKE-Announces-NIKE-FuelBand-%E2%80%93-Measuring-Movement

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HeartCheck Pen Handheld ECG for At-Home Cardiac Monitoring

HeartCheck Pen Handheld ECG for At-Home Cardiac Monitoring

HeartCheck Pen Handheld ECG for At-Home Cardiac Monitoring

Reducing the risk of sudden cardiac death is easy with the HeartCheck™ Pen device.

The new HeartCheck™ Pen device is compact, easy to use, and takes accurate heart readings anytime in only 30 seconds. Storing up to 20 ECGs, data can be downloaded and printed from a computer, or emailed to a physician, clinic, or ECG co-ordinating centre

Heart readings can be taken anytime symptoms appear, which increases the chance of an accurate diagnosis, from anywhere including at home, the office, the gym, or in remote areas which are currently inaccessible to the common ECG machines found in hospitals and clinics.

Features & Benefits

• easy to use

• accurate heart readings in

only 30 seconds

• Store up to 20 ECGs

• ECGs can be printed or downloaded to a computer

• ECGs can be monitored remotely by a physician, clinic, or ECG co-ordinating centre. Recommended use:

• Athletes

• Seniors

• Nursing Homes

• Home care facilities

• and more…

Reducing the risk of sudden cardiac death is easy with the HeartCheck™ Pen device.

The new HeartCheck™ Pen device is compact, easy to use, and takes accurate heart readings anytime in only 30 seconds. Storing up to 20 ECGs, data can be downloaded and printed from a computer, or emailed to a physician, clinic, or ECG co-ordinating centre

Heart readings can be taken anytime symptoms appear, which increases the chance of an accurate diagnosis, from anywhere including at home, the office, the gym, or in remote areas which are currently inaccessible to the common ECG machines found in hospitals and clinics.

Features & Benefits

• easy to use

• accurate heart readings in

only 30 seconds

• Store up to 20 ECGs

• ECGs can be printed or downloaded to a computer

• ECGs can be monitored remotely by a physician, clinic, or ECG co-ordinating centre. Recommended use:

• Athletes

• Seniors

• Nursing Homes

• Home care facilities

• and more…

CardioComm out of Victoria, Canada received marketing clearance from the FDA to bring its HeartCheck Pen Handheld ECG to the U.S.

The device can be used by the patients themselves at home and comes with software the allows recorded telemetry to be uploaded to the company’s C4 medical call service telemedicine group where physicians can analyze the data.

Features from the product page:

• easy to use

• accurate heart readings in only 30 seconds

• Store up to 20 ECGs

• ECGs can be printed or downloaded to a computer

• ECGs can be monitored remotely by a physician, clinic, or ECG co-ordinating centre.

Source : http://www.cardiocommsolutions.com/pen10/index.html

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