Archive for August 30th, 2012

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DESyne BD Coronary Drug Eluting Stent from Elixir Medical Gets Green Light from EU

DESyne BD Coronary Drug Eluting Stent from Elixir Medical Gets Green Light from EU

DESyne BD Coronary Drug Eluting Stent from Elixir Medical Gets Green Light from EU

Sunnyvale, Calif., Aug. 28, 2012—Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

“The CE Mark approval validates the impressive clinical results demonstrated with this stent system, including excellent efficacy and no cases of stent thrombosis through the one-year endpoint,” said Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, co-principal investigator for the EXCELLA BD clinical trial. “The combined attributes of lowest polymer load, lowest drug dose, and thin stent struts provides physicians with a state-of-the-art workhorse product that raises the bar for treating patients with coronary artery disease.”

The Elixir DESyne BD stent uses a proprietary technology to enable an ultrathin (< 3 microns) polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based polymer enables the sustained release of Elixir’s novel therapeutic compound, Novolimus, to the coronary vessel wall and degrades within 6-9 months, leaving behind the cobalt chromium alloy metal stent surface to achieve excellent clinical outcomes.

The Elixir DESyne BD Novolimus Eluting Coronary Stent System was evaluated in the EXCELLA BD randomized clinical trial as compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study enrolled patients in Europe and Brazil.

At six months, the Elixir DESyne BD stent demonstrated not only non-inferiority (p

“The CE Mark approval for the DESyne BD system is a major milestone for Elixir. It reinforces the excellent safety and effectiveness achieved with the CE Mark approved DESyne system, and positions Elixir as the only company to offer both durable and biodegradable polymer DES systems,” said Motasim Sirhan, chief executive officer of Elixir Medical. “Elixir remains committed to providing interventional cardiologists with the broadest and most innovative product portfolio to advance patient care. Elixir intends to launch the DESyne BD system in a broad range of sizes.”

About Elixir Medical

Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent and bioresorbable scaffold systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information about the company, its products and clinical data, please visit http://www.elixirmedical.com.

Sunnyvale, Calif., Aug. 28, 2012—Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

“The CE Mark approval validates the impressive clinical results demonstrated with this stent system, including excellent efficacy and no cases of stent thrombosis through the one-year endpoint,” said Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, co-principal investigator for the EXCELLA BD clinical trial. “The combined attributes of lowest polymer load, lowest drug dose, and thin stent struts provides physicians with a state-of-the-art workhorse product that raises the bar for treating patients with coronary artery disease.”

The Elixir DESyne BD stent uses a proprietary technology to enable an ultrathin (< 3 microns) polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based polymer enables the sustained release of Elixir’s novel therapeutic compound, Novolimus, to the coronary vessel wall and degrades within 6-9 months, leaving behind the cobalt chromium alloy metal stent surface to achieve excellent clinical outcomes.

The Elixir DESyne BD Novolimus Eluting Coronary Stent System was evaluated in the EXCELLA BD randomized clinical trial as compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study enrolled patients in Europe and Brazil.

At six months, the Elixir DESyne BD stent demonstrated not only non-inferiority (p

“The CE Mark approval for the DESyne BD system is a major milestone for Elixir. It reinforces the excellent safety and effectiveness achieved with the CE Mark approved DESyne system, and positions Elixir as the only company to offer both durable and biodegradable polymer DES systems,” said Motasim Sirhan, chief executive officer of Elixir Medical. “Elixir remains committed to providing interventional cardiologists with the broadest and most innovative product portfolio to advance patient care. Elixir intends to launch the DESyne BD system in a broad range of sizes.”

About Elixir Medical

Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent and bioresorbable scaffold systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information about the company, its products and clinical data, please visit http://www.elixirmedical.com.

Source : http://elixirmedical.com/index.php?page=ous-desyne-bd-novolimus-eluting-coronary-stent-system

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Covidien’s New iDrive Ultra Powered Stapling System

Covidien’s New iDrive Ultra Powered Stapling System

Covidien’s New iDrive Ultra Powered Stapling System

Covidien received FDA 510(k) clearance for its iDrive Ultra stapling system, which according to the company is the world’s first “fully powered, reusable, battery-operated endoscopic surgical stapler in the world.”

covidien idrive ultra closeup Covidiens New iDrive Ultra Powered Stapling System (video)

The iDrive Ultra features one handed operation, full articulation of the stapling tool, and help with dexterity since the surgeon doesn’t have to power squeeze the trigger to apply the staples.

More from the press release:

The iDrive Ultra system is the second offering in Covidien’s line of powered stapling devices and the first that is compatible with the Company’s entire portfolio of Endo GIA™ reloads with Tri-Staple™ technology for use in laparoscopic and open surgical procedures. The iDrive Ultra system combines the precision and control of a powered device with proprietary Tri-Staple technology that provides less stress on tissue during compression and clamping, potentially greater perfusion into the staple line and the ability to manage tissue variability.

Source : http://vimeo.com/

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AngioDynamics BioFlo PICC Prevents Clots

AngioDynamics BioFlo PICC Prevents Clots

AngioDynamics BioFlo PICC Prevents Clots

AngioDynamics Earns FDA Clearance for First Vascular Access Product With BioFlo Technology to Reduce Catheter-Related Thrombus

ALBANY, N.Y., Aug. 29, 2012 (GLOBE NEWSWIRE) — AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter. These are the first vascular access products from AngioDynamics to offer BioFlo technology in the U.S. market and an initial launch is expected in the Company’s second quarter of fiscal year 2013. These products are currently CE marked for Europe and are approved in Canada and other international markets.

In vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.* Available with PASV Valve Technology, it is the first catheter that combines all of these properties with AngioDynamics’ patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

“BioFlo technology provides AngioDynamics with a truly disruptive technology which we believe will drive increased demand for our vascular access products,” said Joseph DeVivo, President and CEO of AngioDynamics. “With 15% of the $375 million U.S. PICC market, AngioDynamics holds a strong second position and BioFlo technology is positioned to help us grow that presence. BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics, antimicrobials or any other transient materials typically associated with coated or impregnated technologies.”

A PICC allows intravenous access for an extended period for chemotherapy, antibiotic delivery and other intravascular therapies. The BioFlo PICC is the only PICC manufactured with Endexo technology, a permanent and non-eluting integral polymer. Endexo is blended into the catheter shaft’s polymer, creating a material that provides long-term durability. It is present throughout the catheter shaft material and is not superficial or transient like coatings or impregnated materials. The BioFlo PICC does not contain antibiotics or antimicrobials, agents potentially associated with bacterial resistance.

“We expect to launch BioFlo technology with PASV PICCs in the U.S. within the next 30 days,” said Chuck Greiner, Vice President of the Global Vascular Access Franchise. “Given the early success we have seen during our first market launch in Canada, we are excited to replicate the rapid adoption in the U.S. market. Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters.”

*Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

About AngioDynamics

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, fluid management systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.

Trademarks

AngioDynamics, the AngioDynamics logo, BioFlo and PASV are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Endexo is a trademark of Interface Biologics.

Safe Harbor

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to integrate purchased businesses, including Navilyst Medical and its products, R&D capabilities, infrastructure and employees as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2012. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

Peripherally inserted central catheters (PICCs) are great for keeping patients out of the hospital, but potentially dangerous due to thrombi forming on and within the surface of these devices. All sorts of coatings exist for PICCS to prevent blood coagulation, including those containing anticoagulants like heparin. But the problem persists.

BioFlo Endexo coating AngioDynamics BioFlo PICC Prevents Clots AngioDynamics has received FDA clearance for the BioFlo PICC that takes advantage of Endexo polymer technology to help prevent clot formation. PICC coatings are typically either applied to the surface or impregnated into pores specially formed during manufacturing. The Endexo polymer within the BioFlo is an integral part of the catheter material itself, so it remains permanently on the PICC throughout its lifetime while offering anticoagulant properties similar to devices that elute heparin, according to pre-clinical studies.

From the announcement:

In vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.* Available with PASV Valve Technology, it is the first catheter that combines all of these properties with AngioDynamics’ patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

Source : http://investors.angiodynamics.com/releasedetail.cfm?ReleaseID=702994

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Transcutaneous Vagal Nerve Stimulation, for Airway Diseases and Migraines

Transcutaneous Vagal Nerve Stimulation, for Airway Diseases and Migraines

Transcutaneous Vagal Nerve Stimulation, for Airway Diseases and Migraines

Studies have shown that the vagus nerve is an important component in mediating smooth muscle constriction. Clinical data suggests that Vagus Nerve Stimulation (VNS) can safely induce significant bronchodilation during an asthma exacerbation and may serve as an efficacious treatment for bronchoconstriction.1

Several pre-clinical and clinical studies have been conducted to define the mechanism of action and magnitude and duration of the effect on bronchoconstriction. In several guinea pig & swine studies the treatment system showed significant effectiveness in reducing bronchoconstriction by >60%.1

The vagus nerve is an important structure in parasympathetic and sympathetic tonal balance that mediates smooth muscle activity. The following clinical and animal studies demonstrate the ability of vagus nerve stimulation (VNS) to modulate vagal nerve activity to safely alleviate smooth muscle constriction.

Pre-Clinical

Summary: Inhibition of Histamine-induced Bronchoconstriction in Guinea Pig and Swine by Summary: Pulsed Electrical Vagus Nerve Stimulation

Summary: Low Voltage Vagal Nerve Stimulation Reduces Bronchoconstriction in Guinea Pigs through Catecholamine Release

Summary: Evaluation of Vagal Nerve Stimulation in Ragweed Sensitized Beagle Dogs: Methalcholine Induced Bronchoconstriction

Clinical

Summary: Feasibility of Percutaneous Vagus Nerve Stimulation for the Treatment of Acute Asthma Exacerbations

Summary of Pre-Clinical & Clinical Findings

Vagal Nerve Stimulation (VNS) inhibits bronchoconstriction through an afferent pathway, causing an endogenous release of catecholamines.

There was no clinically significant change in heart rate or blood pressure in studies of the company’s proprietary electrical stimulation waveform [of the AlphaCore] on guinea pigs, dogs, and humans.

Percutaneous devices demonstrated clinically significant improvement in Forced Expiratory Volume (FEV1) and Work Of Breathing (WOB).

Non Invasive Vagus Nerve Stimulation (nVNS) is as effective as albuterol at 2 hrs in treating asthma exacerbations.

Preliminary animal and clinical data suggest that nVNS may provide an effective option for treating bronchoconstriction in patients who cannot tolerate the adverse cardiac effects of albuterol or other inhaled short-term beta-agonists or whose airway resistance is too high to get adequate benefit from inhaled medications in a timely manner.

These data, suggest that the AlphaCore™ device is a safe and effective treatment for acute bronchoconstriction associated with reactive airway diseases (e.g., asthma exacerbations).

Mark Pawanker, R., Canonica, G.W., Holgate, S.T., Locke, R.F. World Allergy Organization (WAO) White Book on Allergy. World Allergy Organization. 2011.

Clinical Study Content

Summary: Inhibition of Histamine-induced Bronchoconstriction in Guinea Pig and Swine by Pulsed Electrical Vagus Nerve Stimulation¹

The goal of this study was to determine whether applying a low-voltage electrical signal to the vagus nerve could reduce histamine-induced bronchoconstriction in swines and guinea pigs. Sixteen guinea pigs were anesthetized and had bipolar electrodes positioned on the cervical vagus nerves.

Intravenous histamine was titrated to elicit a moderate 2–4 cm H2O increase in pulmonary inflation pressure (Ppi). Histamine was then administered with or without concurrent VNS. The peak change in Ppi following a histamine challenge was reduced in the guinea pigs by VNS stimulation by approximately 60%.

Figure 1. VNS inhibits histamine-induced bronchoconstriction.

Similar results were confirmed in a study in swine indicating VNS is applicable to larger animals. These studies suggest that VNS can reduce bronchoconstriction and may prove useful as a therapy in the treatment of reactive airway disease.

¹Hoffman, T.J., Mendez, S., Staats, P., Emala, C.W., Guo, P. Neuromodulation: Technology at the Neural Interface 2009.

Summary: Low Voltage Vagal Nerve Stimulation Reduces Bronchoconstriction in Guinea Pigs through Catecholamine Release²

The purpose of this study was to determine the mechanism of action by which VNS reduces bronchoconstriction in guinea pigs. To test whether VNS acted through an efferent or afferent vagal pathway, investigators ligated the vagal nerves either rostral or caudal to the electrode. Tying the vagus nerves caudal had no effect (Figure 2).

Figure 2. Tying vagal nerves caudal to electrodes does not block VNS

However, when the vagus nerves were ligated rostral to the electrodes, VNS no longer inhibited histamine-induced bronchoconstriction (Fig. 3). These unexpected findings suggest that VNS inhibits bronchoconstriction through an afferent, rather than efferent pathway.

Figure 3. Tying vagal nerves rostral to electrodes blocks VNS

In another experiment, the ?-blocker propranolol was shown to inhibit the VNS effect suggesting a role for catecholamines in the mechanism of VNS bronchoprotection (Fig. 4). This was further supported by the measurement of elevated serum catecholamines after VNS, which correlated with the degree of suppression of the histamine-induced constriction.

Figure 4. Propranolol inhibits VNS

The results from these studies suggest that relief from airway constriction through VNS may result from a parasympathetic-sympathetic reflex arc. An afferent signal travels up to the central nervous system, causing a sympathetically-mediated release of catecholamines. Catecholamines relax smooth muscles in the airway, relieving bronchoconstriction.

²Hoffman, T.J., Simon, B.J., Zhang, Y., Emala, C.W. Respir Physiol Neurobiol. 2012 (In press).Hoffman, T.J., Simon, B.J., Zhang, Y., Emala, C.W. Respir Physiol Neurobiol. 2012 (In press).

Summary: Development of Non-Invasive Vagal Nerve Stimulator for Treatment of Acute Asthma Exacerbations³

A proprietary, non-invasive VNS (nVNS) device (AlphaCore™) was developed and tested in an established hypersensitive beagle asthma model to confirm that it had a similar safety and efficacy profile as the pVNS device described above Dogs were subjected to methacholine (Mch) challenges inducing about a 100% increase in airway resistance. Dogs were then treated with the AlphaCore™ device for 2 minutes and repeatedly challenged with the same dose of Mch at 1, 15 and 30 min and every 30 min thereafter for up to 2 hours. Changes in airway resistance, BP and HR were monitored during nVNS.

In a second experiment propranolol was given by i.v. prior to either albuterol or nVNS Treatment with AlphaCore™ resulted in a significant reduction in methacholine-induced bronchoconstriction, which occurred within 1 minute of nVNS and lasted for up to 2 hours, with no significant changes in BP or HR. These results are comparable to historical results with albuterol in the same model (Fig. 7). Further, propranolol inhibited the effects of albuterol and nVNS, suggesting that the mechanism of nVNS involves ?-receptor stimulation through the release of catecholamines.

Summary: Feasibility of Percutaneous Vagus Nerve Stimulation for the Treatment of Acute Asthma Exacerbations 4

The purpose of this study was to investigate both the safety and efficacy of VNS delivered through a percutaneous electrode (pVNS) for the treatment of acute asthma exacerbations. The study subjects were limited to consenting adult patients with no further respiratory problems or other pre-existing medical conditions. 24 ED patients (ages 18-65 years) who failed to respond to one hour of standard of care (SOC) were treated with the percutaneous placement of an electrode near the right carotid sheath and then administered 60 minutes of pVNS and SOC. They were compared with a non-randomized control group of 57 subjects.

The primary study outcome measures included adverse events, Force Expiratory Volume in 1 sec (FEV1), and improvement in perceived Work of Breathing (WOB) measured on a visual analogue scale. Stimulation for 60 minutes showed remarkable improvement in both FEV1 (Fig. 5) and WOB (Fig. 6) without serious adverse events

ement in WOB

A battery-powered gadget the size and shape of an electric shaver may be a new way to treat painful headaches.

Studies suggest the device – which is held against the neck for 90 seconds – may reduce the severity of migraine and cluster headache attacks, and even prevent them.

Researchers say that for some patients the device may be as effective as drugs, without any negative side effects. It has also worked for patients who have not responded to drugs.

Results of the first trials are expected to show a 50 per cent reduction in symptoms in half of patients.

Both migraine and cluster headaches are significant health problems in the UK.

An estimated 5.6 million people have migraine attacks, on average once a month, with three times as many women as men affected. The cause is unknown, but levels of serotonin, the so-called feel-good chemical, drop during a migraine.

Although drug treatments are effective for many patients, they do not work for all and can have side effects.

Cluster headaches, in which the attacks occur in succession or ‘clusters’, are less common, affecting around one in 1,000 people and mostly men. The pain, usually around one eye or the temple, is described by sufferers as excruciating.

The new device, developed by US-based ElectroCore, generates electrical signals and is held against the right side of the neck on the skin above the pulse of the carotid artery. A conductive gel is placed on the device to increase its effectiveness.

The gadget is available in Europe for professional and home use, but a doctor’s authorisation is required

The gadget is available in Europe for professional and home use, but a doctor’s authorisation is required

A small wheel is used to adjust the stimulation until moderate muscle-twitching is felt, with that power maintained for 90 seconds. In severe cases, multiple applications may be required.

Exactly how it works is not clear. One theory is it increases levels of the neurotransmitters serotonin and noradrenaline, which reduces pain perception.

The device is being tested in the US and Europe, including a study of around 50 patients at London’s Royal Free Hospital and a site in Dublin.

The gadget is available in Europe for professional and home use, but a doctor’s authorisation is required. It costs £250 for a device with 150 treatments, and £150 for one with 50 treatments.

Source : http://www.dailymail.co.uk/health/article-2190266/Gadget-zap-agony-migraine.html

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GE’s New Protein Purification System: ÄKTA pure

GE’s New Protein Purification System: ÄKTA pure

GE’s New Protein Purification System: ÄKTA pure

Chalfont St Giles, UK – 24 August 2012 – GE Healthcare, the healthcare business of GE (NYSE: GE) announced today the launch of ÄKTA™ pure, a chromatography system for flexible, reliable and intuitive purification of proteins. ÄKTA pure, the latest addition to the industry-leading ÄKTA range of chromatography systems, is an easy-to-use modular system that offers the flexibility to support both routine and challenging purification requirements, as well as being adaptable to changing research needs.

Johan von Heijne, Head of Research Products, GE Healthcare Life Sciences, said, “In an increasingly challenging research environment, where needs and priorities can change rapidly, researchers want to know that the protein purification system they purchase has longevity. By taking a modular approach with ÄKTA pure, we are providing a system that not only simplifies researchers’ work but also gives them a flexible option for expanding and tailoring their purification capabilities as their research progresses. There is simply an ÄKTA pure for everyone.”

In today’s research environment, scientists are often expected to undertake all aspects of the protein discovery workflow, from genomics through to purification and characterisation, and the requirement to isolate specific proteins at high purity in short timelines often means that chromatography conditions and methodologies have become more challenging. ÄKTA pure is specifically designed to enable researchers – from beginners to experts – to easily isolate their target protein, whether under simple or complex conditions.

ÄKTA pure eliminates the need for programming skills to control the chromatography run, with the addition of simple drag-and-drop method templates in the UNICORN™ 6 control software. Through the software it is also possible to electronically track the use of, and data obtained from, individual columns, which is particularly useful as chromatography systems are often placed in shared facilities.

For further information please visit http://www.gelifesciences.com/aktapure

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

GE Healthcare is releasing its new ÄKTA pure chromatography system for protein purification. The company promises that the system can purify any protein or biomolecule that a study requires.

The device was designed for ease of use with software that doesn’t require programming skills, but rather relies on a drag and drop interface. The modular design allows different pumps and valves and other hardware to be integrated as needed.

From the announcement:

In today’s research environment, scientists are often expected to undertake all aspects of the protein discovery workflow, from genomics through to purification and characterisation, and the requirement to isolate specific proteins at high purity in short timelines often means that chromatography conditions and methodologies have become more challenging. ÄKTA pure is specifically designed to enable researchers – from beginners to experts – to easily isolate their target protein, whether under simple or complex conditions.

ÄKTA pure eliminates the need for programming skills to control the chromatography run, with the addition of simple drag-and-drop method templates in the UNICORN™ 6 control software. Through the software it is also possible to electronically track the use of, and data obtained from, individual columns, which is particularly useful as chromatography systems are often placed in shared facilities.

This week in Munich, Germany, some of the world’s top cardiologists are gathering for the 60th annual European Society of Cardiology conference. One of the new GE ultrasound systems being showcased for the first time at the congress is the Vivid E9 BT 12 with 4D TEE probe. Hear below what Dr. Luigi Badano from Italy and Professor Reidar Winter from Sweden have to say about their experiences with the new GE cardiovascular ultrasound system and the impact it is having on the care they provide to patients.

Source : http://newsroom.gehealthcare.com/

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High Speed Deformability Cytometer Feels Through Thousands of Cells a Second

High Speed Deformability Cytometer Feels Through Thousands of Cells a Second

High Speed Deformability Cytometer Feels Through Thousands of Cells a Second

When cells hit the wall: UCLA engineers put the squeeze on cells to diagnose disease

cytometer-dicarlo-300px-1

An artist’s depiction of a cell being squeezed in a high speed fluid flow

By Wileen Wong Kromhout and Matthew Chin

If you throw a rubber balloon filled with water against a wall, it will spread out and deform on impact, while the same balloon filled with honey, which is more viscous, will deform much less. If the balloon’s elastic rubber was stiffer, an even smaller change in shape would be observed.

By simply analyzing how much a balloon changes shape upon hitting a wall, you can uncover information about its physical properties.

Although cells are not simple sacks of fluid, they also contain viscous and elastic properties related to the membranes that surround them; their internal structural elements, such as organelles; and the packed DNA arrangement in their nuclei. Because variations in these properties can provide information about cells’ state of activity and can be indicative of diseases such as cancer, they are important to measure.

UCLA bioengineering researchers have taken advantage of cells’ physical properties to develop a new instrument that slams cells against a wall of fluid and quickly analyzes the physical response, allowing for the identification of cancer and other cell states without expensive chemical tags.

The instrument, called a deformability cytometer, was developed by UCLA biomedical engineering doctoral students Daniel Gossett and Henry Tse and assistant professor of bioengineering Dino Di Carlo. It consists of a miniaturized microfluidic chip that sequentially aligns cells so that they hit a wall of fluid at rates of thousands of cells per second. A specialized camera captures microscopic images of these cells at intervals of 140,000 pictures per second, and these images are then automatically analyzed by custom software to extract information about the cells’ physical properties.

cytometer-dicarlo-300px-2

Mechanical properties can be gleaned by watching a water balloon hit a wall (top) and a cell hit a wall of fluid (bottom)

Other researchers had previously discovered that the physical properties of cells could provide useful information about cell health, but previous techniques had been confined to academic research labs because measuring the cells of interest could take hours or even days. Using the deformability cytometer, the group can prepare the samples and conduct the analysis for tens of thousands of cells with the instrument within ten to 30 minutes.

“Our system makes use of an approach that (U.S. Secretary of Energy) Steven Chu used to stretch DNA to, instead, stretch cells,” Di Carlo said. “This required us to engineer the fluid dynamics of the system such that cells always entered the stretching flow in the same place, making use of inertial focusing technology my group has been pioneering.”

With a system in place to measure the physical properties of cells at much higher rates, the bioengineers teamed up with collaborators across the UCLA campus to measure various cell populations of interest to biologists and doctors.

Along with UCLA stem cell biologist Amander Clark, an assistant professor of of molecular, cellular and developmental biology, Di Carlo’s team confirmed that stem cells that have the capability to become any tissue type stretched much less than their progeny, which were already in the process of becoming a particular tissue.

In collaboration with cytopathologist Dr. Jian Yu Rao, a professor of pathlogy and laboratory medicine at the David Geffen School of Medicine at UCLA, the team accurately detected cancer cells from pleural fluids using the high-speed deformability cytometer. Pleural fluid, which builds up around the lungs, is traditionally challenging to analyze because it contains a mixture of cell types — including immune cells, mesothelial cells from the chest wall lining and, potentially, low concentrations of cancer cells.

“The main problem for the diagnosis is that with cytomorphology alone, it can be difficult to distinguish non-malignant mesothelial cells that are reactive to conditions such as inflammation, infection and injury, versus metastatic cancer cells or malignant mesothelial cells,” Rao said. “So this technique has tremendous clinical utility in that regard.”

With Rao and Dr. Otto Yang, a professor with the infectious diseases division at the Geffen School of Medicine and the department of microbiology, immunology and molecular genetics, the researchers found that in addition to identifying cancer, the technique was also sensitive to states of acute and chronic inflammation in which populations of white blood cells are primed to respond to infection. Measuring the state of the immune system can aid in diagnosing immune disorders such as AIDS or in evaluating patients’ rejection of transplants early on, allowing doctors to modify anti-rejection therapies.

“The applicability to infectious diseases and organ transplantation is still theoretical,” said Yang, who is also a researcher with the UCLA AIDS Institute. “Immune cells change physical characteristics as they are activated, and so, in theory, this technology could be harnessed to detect immune responses against infections or transplanted organs.”

“Working with other folks across campus has been amazing,” Di Carlo said. “Anytime we talked with Amander, Otto or Jian Yu, we learned something new which helped us refine our system and the problems we chose to address. We all live in slightly different worlds, and sometimes communication is difficult, but bioengineering is great in that we can communicate in different languages and bridge the engineering school to medicine and biology much more effectively.”

The results were reported online in the journal Proceedings of the National Academy of Sciences of the USA and will be published in a forthcoming print issue of the journal. More information can be found at Di Carlo’s laboratory website.

The research was funded by a Young Faculty Award from the Defense Advanced Research Projects Agency (DARPA) and a Packard Foundation Fellowship for Science and Engineering.

Cytovale Inc., a spin-off out of UCLA Engineering assisted by the school’s Institute for Technology Advancement, is exploring first steps toward commercialization of the instrument.

Malignant cells are different from regular cells in their biochemistry as well as in their morphology. Studying physical properties of such cells can often be more advantageous than looking at their biochemical characteristics because labeling is not required and sample preparation is easier to perform.

Scanning through thousands of cells to spot a cancerous one requires a fast device, and researchers at UCLA have developed one called deformability cytometer that can effectively “feel” around the entire perimeter of individual cells, using a liquid flow trap, at 2,000 cells per second.

Some details about the workings of the system:

It consists of a miniaturized microfluidic chip that sequentially aligns cells so that they hit a wall of fluid at rates of thousands of cells per second. A specialized camera captures microscopic images of these cells at intervals of 140,000 pictures per second, and these images are then automatically analyzed by custom software to extract information about the cells’ physical properties.

mechanical properties of cells High Speed Deformability Cytometer Feels Through Thousands of Cells a Second

Mechanical properties can be gleaned by watching a water balloon hit a wall (top) and a cell hit a wall of fluid (bottom) – UCLA

Other researchers had previously discovered that the physical properties of cells could provide useful information about cell health, but previous techniques had been confined to academic research labs because measuring the cells of interest could take hours or even days. Using the deformability cytometer, the group can prepare the samples and conduct the analysis for tens of thousands of cells with the instrument within ten to 30 minutes.

“Our system makes use of an approach that (U.S. Secretary of Energy) Steven Chu used to stretch DNA to, instead, stretch cells,” [assistant professor of bioengineering Dino] Di Carlo said. “This required us to engineer the fluid dynamics of the system such that cells always entered the stretching flow in the same place, making use of inertial focusing technology my group has been pioneering.”

With a system in place to measure the physical properties of cells at much higher rates, the bioengineers teamed up with collaborators across the UCLA campus to measure various cell populations of interest to biologists and doctors.

Along with UCLA stem cell biologist Amander Clark, an assistant professor of of molecular, cellular and developmental biology, Di Carlo’s team confirmed that stem cells that have the capability to become any tissue type stretched much less than their progeny, which were already in the process of becoming a particular tissue.

Cell state is often assayed through measurement of biochemical and biophysical markers. Although biochemical markers have been widely used, intrinsic biophysical markers, such as the ability to mechanically deform under a load, are advantageous in that they do not require costly labeling or sample preparation. However, current techniques that assay cell mechanical properties have had limited adoption in clinical and cell biology research applications. Here, we demonstrate an automated microfluidic technology capable of probing single-cell deformability at approximately 2,000 cells/s. The method uses inertial focusing to uniformly deliver cells to a stretching extensional flow where cells are deformed at high strain rates, imaged with a high-speed camera, and computationally analyzed to extract quantitative parameters. This approach allows us to analyze cells at throughputs orders of magnitude faster than previously reported biophysical flow cytometers and single-cell mechanics tools, while creating easily observable larger strains and limiting user time commitment and bias through automation. Using this approach we rapidly assay the deformability of native populations of leukocytes and malignant cells in pleural effusions and accurately predict disease state in patients with cancer and immune activation with a sensitivity of 91% and a specificity of 86%. As a tool for biological research, we show the deformability we measure is an early biomarker for pluripotent stem cell differentiation and is likely linked to nuclear structural changes. Microfluidic deformability cytometry brings the statistical accuracy of traditional flow cytometric techniques to label-free biophysical biomarkers, enabling applications in clinical diagnostics, stem cell characterization, and single-cell biophysics.

Source : http://www.engineer.ucla.edu/newsroom/featured-news/archive/2012/

www.when-cells-hit-the-wall-ucla-engineers-put-the-squeeze-on-cells-to-diagnose-disease

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Crowdsourced Pathology, Thanks to Video Gamers

Crowdsourced Pathology, Thanks to Video Gamers

Crowdsourced Pathology, Thanks to Video Gamers

Online crowd-sourcing — in which a task is presented to the public, who respond, for free, with various solutions and suggestions — has been used to evaluate potential consumer products, develop software algorithms and solve vexing research-and-development challenges. But diagnosing infectious diseases?

Working on the assumption that large groups of public non-experts can be trained to recognize infectious diseases with the accuracy of trained pathologists, researchers from the UCLA Henry Samueli School of Engineering and Applied Science and the David Geffen School of Medicine at UCLA have created a crowd-sourced online gaming system in which players distinguish malaria-infected red blood cells from healthy ones by viewing digital images obtained from microscopes.

The UCLA team found that a small group of non-experts playing the game (mostly undergraduate student volunteers) was collectively able to diagnosis malaria-infected red blood cells with an accuracy that was within 1.25 percent of the diagnostic decisions made by a trained medical professional.

The game, which can be accessed on cell phones and personal computers, can be played by anyone around the world, including children.

“The idea is, if you carefully combine the decisions of people — even non-experts — they become very competitive,” said Aydogan Ozcan, an associate professor of electrical engineering and bioengineering and the corresponding author of the crowd-sourcing research. “Also, if you just look at one person’s response, it may be OK, but that one person will inevitably make some mistakes. But if you combine 10 to 20, maybe 50 non-expert gamers together, you improve your accuracy greatly in terms of analysis.”

Crowd-sourcing, the UCLA researchers say, could potentially help overcome limitations in the diagnosis of malaria, which affects some 210 million people annually worldwide and accounts for 20 percent of all childhood deaths in sub-Saharan Africa and almost 40 percent of all hospitalizations throughout that continent.

The current gold standard for malaria diagnosis involves a trained pathologist using a conventional light microscope to view images of cells and count the number of malaria-causing parasites. The process is very time-consuming, and given the large number of cases in resource-poor countries, the sheer volume presents a big challenge. In addition, a significant portion of cases reported in sub-Sahara Africa are actually false positives, leading to unnecessary and costly treatments and hospitalizations.

By training hundreds, and perhaps thousands, of members of the public to identify malaria through UCLA’s crowd-sourced game, a much greater number of diagnoses could be made more quickly — at no cost and with a high degree of collective accuracy.

“The idea is to use crowds to get collectively better in pathologic analysis of microscopic images, which could be applicable to various telemedicine problems,” said Sam Mavandadi, a postdoctoral scholar in Ozcan’s research group and the study’s first author.

Ozcan and Mavandadi emphasized that the same platform could be applied to combine the decisions of minimally trained health care workers to significantly boost the accuracy of diagnosis, which is especially promising for telepathology, among other telemedicine fields.

The new UCLA study, “Distributed Medical Image Analysis and Diagnosis Through Crowd-Sourced Games,” has been accepted for publication in the journal PLoS ONE. More information is available at http://biogames.ee.ucla.edu.

In addition to developing the crowd-sourced gaming platform that allows players to assist in identifying malaria in cells imaged under a light microscope, Ozcan’s research group created an automated algorithm for diagnosing the same images using computer vision, as well as a novel hybrid platform for combining human and machine resources toward efficient, accurate and remote diagnosis of malaria.

“The most exciting aspect is that this is an entirely novel approach in the area of visual diagnostics, which really challenges diagnostic algorithms used to date,” said Karin Nielsen, a professor of infectious diseases in the department of pediatrics at the Geffen School of Medicine. “It is diagnostics outside the box — that is, the study introduces an entirely new concept in diagnostics with the use of games for this purpose. The potential applications of this new approach are immense.”

How the game works:

Before playing the game, each player is given a brief online tutorial and an explanation of what malaria-infected red blood cells typically look like using sample images. After completing a short training phase, players go through the actual game, in which they are presented with multiple frames of red blood cell images and can use a “syringe” tool to “kill” the infected cells one-by-one and use a “collect-all” tool to designate the remaining cells in the frame as “healthy.”

crowdsource-malaria-ozcan1-300px.jpg

Sample game screen

Within each frame, there are a certain number of cells whose status (i.e., infected or not) is known by the game but not by the players. These control cell images allow Ozcan’s team to dynamically estimate the performance of gamers as they go through each frame and also helps the team assign a score for every frame the gamer passes through.

“I believe that, similar to other very innovative ideas, one of the major challenges will be the skepticism of traditional microscopists, pathologists and clinical laboratory personnel, not to mention malaria experts, who will initially view with suspicion a gaming approach in malaria diagnostics,” said Nielsen, also an author of the study. “It is a very revolutionary proposal and it might take a few clinical studies in the field to document the efficacy of this platform in order to convince traditional microbiologists and other infectious disease colleagues.”

“Scaling up accurate, automated and remote diagnosis of malaria through a crowd-sourced gaming platform may lead to significant changes for developing countries,” Ozcan said.

“It could eliminate the current overuse and misuse of anti-malarial drugs, improve management of non-malaria fevers by ruling malaria out, lead to better use of existing funds, and reduce risks due to long-term side-effects of anti-malarial drugs on patients who don’t need treatment,” Mavandadi added.

Ozcan’s team hopes to bring the platform into the field through clinical trials to help validate its use and facilitate implementation of the technology worldwide. Nielsen and Ozcan plan to implement it at clinical sites in countries such as Mozambique, Malawi and Brazil.

In addition, the same crowd-sourcing and gaming-based micro-analysis and medical diagnosis platform could be further scaled up for a variety of other biomedical and environmental applications in which microscopic images need to be examined by experts, the researchers said.

Other authors of the study included Stoyan Dimitrov, Steve Feng, Frank Yu, Uzair Sikora, Oguzhan Yaglidere and Swati Padmanabhan, all with the UCLA Department of Electrical Engineering.

Funding for Ozcan Research Group is provided by the Presidential Early Career Award for Scientists and Engineers (PECASE), the Army Research Office Young Investigator Award, the NSF CAREER Award (BISH Program), the Office of Naval Research Young Investigator Award 2009 and the NIH Director’s New Innovator Award.

Researchers from UCLA’s School of Engineering and Applied Science and the School of Medicine have designed a system that can harness distant groups of people to analyze pathology images for signs of disease. They tested the ability of non-professionals to quickly learn to detect malaria when looking at images of red blood cells and have shown that if necessary, with a bit of help from online crowds, large groups of people can potentially be screened for the disease.

The system they built relies on video gaming to attract people to do the visual tasks necessary to spot malaria. The study subjects, mostly untrained newbie undergrads, showed a spotting ability that was within 1.25 percent of medical professionals.

malaria app Crowdsourced Pathology, Thanks to Video Gamers

Results from the study info page:

We have shown that by utilizing the innate visual recognition and learning capabilities of human crowds it is possible to conduct reliable microscopic analysis of biomedical samples and make diagnostics decisions based on crowd-sourcing of microscopic data through intelligently designed and entertaining games that are interfaced with artificial learning and processing back-ends. We demonstrated that in the case of binary diagnostics decisions (e.g., infected vs. uninfected), using crowd-sourced games it is possible to approach the accuracy of medical experts in making such diagnoses.

Specifically, using non-professional gamers we report diagnosis of malaria infected red-blood-cells with an accuracy that is within 1.25% of the diagnostic decisions made by a trained professional.

source : http://www.engineer.ucla.edu/newsroom/featured-news/archive/2012/

www.game-on-ucla-researchers-use-online-crowd-sourcing-to-diagnose-malaria

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Electron Microscopy in Stunning, Real-Time 3D – Coming Soon to a Laboratory Near You!

Electron Microscopy in Stunning, Real-Time 3D – Coming Soon to a Laboratory Near You!

Electron Microscopy in Stunning, Real-Time 3D – Coming Soon to a Laboratory Near You!

Japan Science and Technology Agency (JST) announced April 26, 2012, that a Japanese research group developed a scanning electron microscope (SEM) capable of showing a 3D image in real time and a high-resolution naked-eye 3D monitor for the SEM.

The group consists of researchers from Hitachi High-Technologies Corp, Eizo Nanao Corp, Niigata University, Shizuoka University, etc. The new SEM is expected to be used not only for analyzing the structure of an object but for microanatomy using a manipulator and measuring electrical characteristics of inorganic materials.

Scanning while switching direction of electron beam

With an SEM, three-dimensional structures (convex and concave structures) on the surface of an object are observed by emitting a narrowed electron beam to the object and two-dimensionally scanning it. Normal SEMs show images that are observed from one direction. Therefore, those images are two-dimensional as if they are seen by one eye.

For obtaining three-dimensional images by using normal SEMs, it is necessary to synthesize still images equivalent to images seen by the right and left eyes (parallax images) after taking those images from different angles by tilting the stage and to observe them with red/blue glasses, etc. However, with this method, it takes time to obtain and make adjustment to parallax images, and it is not possible to observe the SEM image of a specimen in real time.

This time, the research group developed a technology to scan a specimen at high speeds while switching the angle of an electron beam directed at a specimen and succeeded in instantly obtaining right and left parallax images. Specifically, an electron beam is slanted by the converging effect of the electromagnetic lens.

Though the aberration caused by slanting an electron beam lowers resolution, the group developed a new electro-optical system and a scan control technology for electron beam and applied them for the SEM.

The control of the direction of electron beam’s tilt is conducted by using a special magnet coil and switching among left-leaning scanning, normal scanning, right-leaning scanning, etc for each line and frame. As a result, the research group realized a high scanning speed of 33ms/frame and real-time 3D observation.

The focus and astigmatism of the right and left parallax images are different from those of normal SEM images because of the use of the converging effect of the lens. But they can be adjusted for each line and frame.

Over at the Japan Science and Technology Agency (JST), researchers have developed a special scanning electron microscope (SEM) capable of generating high-resolution 3D images of the study subject. 3D SEM is actually not new technology, however, the JST SEM is the first device of its kind that can show 3D images in real-time. The secret is a special electromagnetic lens that slants an electron beam aimed at a specimen, which results in instant left and right parallax images needed to create a 3D effect. Normal 3D SEM imaging techniques require the left and right parallax images to be taken separately and at different angles.

If you have a pair of red/blue 3D glasses, be sure to take a look at the above anaglyph of a piece of metal, produced by the JST SEM.

Researchers hope that this new method of microscopy will not only allow for better study of a specimen’s structure, but also for exploring microanatomy and measuring the specimen’s electrical characteristics.

This might actually be a 3D technology worth shelling out a few extra dollars!

Source : http://techon.nikkeibp.co.jp/english/NEWS_EN/20120502/215894/

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iBGStar Glucometer for iPhone Now Available in U.S.

iBGStar Glucometer for iPhone Now Available in U.S.

iBGStar Glucometer for iPhone Now Available in U.S.

BRIDGEWATER, N.J., – May 2, 2012 /PRNewswire/ — Sanofi US announced today that the iBGStar® Blood Glucose Monitoring System, consisting of the iBGStar® blood glucose meter and iBGStar® Diabetes Manager App, is commercially available in the U.S. iBGStar® is the first Food and Drug Administration (FDA) cleared blood glucose meter that directly connects to the iPhone® and iPod touch®, offering accurate blood glucose monitoring that seamlessly integrates into the lives of people with diabetes. iBGStar® is available for purchase at Apple® Retail Stores and all Walgreens stores nationwide, online at Apple.com, Walgreens.com and through Diabetic Care Services.

“Many people with diabetes today rely both on their iPhone® or iPod touch® and blood glucose monitors as important parts of their daily lives,” said Naina Sinha, MD, an in-patient diabetes attending physician and assistant professor of medicine at a leading academic medical center and university in New York City. “By combining these two essential tools, iBGStar® makes it possible to provide blood glucose tracking, monitoring and reporting together in a new way.”

About iBGStar®

When iBGStar® is directly connected to an iPhone® or iPod touch® and used with the iBGStar® Diabetes Manager App, blood glucose results are presented on the Multi-Touch display quickly after monitoring.

iBGStar® can also be used independently to measure blood glucose levels; results can be synchronized later to an iPhone® or iPod touch®. iBGStar® and BGStar® Blood Glucose Test Strips, which are used with iBGStar®, are available at all Walgreens stores nationwide and online at Walgreens.com and through Diabetic Care Services. These test strips may be covered under certain health insurance plans so individuals should check directly with their provider.

The iBGStar® Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on-the-go. Visual graphs and statistics can help people record and track their readings, carbohydrate intake, insulin doses (if taking insulin) and more. Color-coded scorecards show individual monitoring results for easy identification of high or low blood glucose levels. A ‘share’ function allows specific data to be sent via e-mail to caregivers and/or healthcare teams. The iBGStar® Diabetes Manager App is available for free from the App Store on iPhone® and iPod touch® or at www.itunes.com/appstore.

“Sanofi is pleased to launch iBGStar®, which expands our diabetes portfolio as we pursue comprehensive disease management offerings and further illustrates our commitment to developing innovative solutions that help improve the lives of people with diabetes,” commented Dennis Urbaniak, Vice President, Head of U.S. Diabetes, Sanofi US. “The iBGStar® Blood Glucose Monitoring System will help people living with diabetes check their blood sugar and communicate with their healthcare teams, using mobile technologies that have become central to so many people’s lives.”

In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring solutions. iBGStar® is a result of this agreement.

iBGStar® received the Good Design™ Award in 2011 for outstanding product design in the medical category from the Chicago Athenaeum of Architecture and Design and the European Centre for Architecture Art Design and Urban Studies. Additionally, iBGStar® received the red dot design award in 2011 for outstanding product design in the life science and medicine category. The red dot design award is one of the most renowned international design competitions (www.red-dot.de/presse), with almost 14,000 entries from 68 countries in 2010 alone. Winners are considered to be the best design in the industry worldwide.

Apple®, iPhone® and iPod touch® are trademarks of Apple Inc, registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes Store is for personal lawful use only. Don’t steal music.

For more information, visit www.ibgstar.us.

Important Information

The iBGStar® meter and lancing device are for single patient use. Do not share them with anyone including other family members. Do not use on multiple patients. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

About the Sanofi Diabetes Division

Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Sanofi has announced that its iBGStar, the first approved blood glucose meter to interface with the iPhone, is now available in the U.S. The device will display glucose readings on the iPhone (or iPod touch) screen and those will be saved for long term analysis. On the other hand, if your iPhone is out of power or you managed to lose it, fear not, the iBGStar dock will work independently and provide readings on its own little display. While disconnected from the iPhone, the meter will save glucose levels it measures locally until it is back in touch with the phone.

Sanofi is reporting that the new glucometer is available from Apple and Walgreens at both their retail and online stores.

More from Sanofi:

The iBGStar® Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on-the-go. Visual graphs and statistics can help people record and track their readings, carbohydrate intake, insulin doses (if taking insulin) and more. Color-coded scorecards show individual monitoring results for easy identification of high or low blood glucose levels. A ‘share’ function allows specific data to be sent via e-mail to caregivers and/or healthcare teams. The iBGStar® Diabetes Manager App is available for free from the App Store on iPhone® and iPod touch® or at www.itunes.com/appstore.

In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring solutions. iBGStar® is a result of this agreement.

Source : http://www.multivu.com/mnr/46108-sanofi-ibgstar-blood-glucose-monitoring-system

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Thieme Debuts Proprietary eBook App for iPad

Thieme Debuts Proprietary eBook App for iPad

Thieme Debuts Proprietary eBook App for iPad

Description

Thieme Bookshelf is the companion app to Thieme’s E-Book Store, where you can purchase from among hundreds of books specializing in the latest medical content. Browse the contents of the store or your personal library with an easy-to-use bookshelf; tap a book to open it; flip through pages with a swipe or a tap; and bookmark or add notes to your favorite passages.

- performance improvements.

- iPad3 retina display support.

- performance improvement.

- fixed an issue related to downloading eBooks.

Medical publisher Thieme recently debuted their own free iBooks-like app for the iPad. This is an interesting way for medical publishers to start their own eco-systems, allowing institutional and personal subscriptions that don’t rely on a single platform. Already accessible through their web portal, in the future they could expand to Android tablets or whatever else comes along. It doesn’t anchor users to Apple, but it does keep them with Thieme, and prevents the end user from selling a used copy. Like with most electronic media, users want to access their purchases with whatever device they happen to have on hand, and since most physicians are using an iPad for a tablet, Thieme seems to be responding appropriately.

The app itself is pretty basic, serving as both a bookshelf and a portal to their eBook store, but we don’t know that you would want it to do much more. It downloads purchased books through the storefront in the app, or when you sign in with your Thieme username you get access to all of the eBook versions of Thieme books you already own on other devices. The files are saved on the iPad, so you don’t need internet access once the book is downloaded. We looked at three titles that Thieme provided free for review:

Thieme bookshelf Thieme Debuts Proprietary eBook App for iPadAtlas of Anatomy

Peripheral Regional Anesthesia

Surgical Treatment of Orthopaedic Trauma

Within each book you can make bookmarks and notes, search for keywords, and alter the screen contrast. However, when a book comes with “bonus content” such as videos or DVDs there is no way to get to them within the app. The publishers tell us that they hope to add this functionality in the future. Also, there is no way to share notes or bookmarks with others who own the same book or with yourself on another device. Annoyingly, if you leave a book to go to another part of the app, when you return to the book the program does not save your place, dumping you back to the first page. This is made even more frustrating by the slowness of the app in rendering each page. We were using the latest generation iPad and it took about 3 seconds to render each page (slightly faster in landscape mode, but the text is smaller), making casual scrolling through a book very tedious. So unless you remember the exact page number you were on before exiting or made a bookmark, getting back to where you were could involve a lot of idle time.

A final minor complaint is that the title of the app itself (Thieme Bookshelf) is long enough that it has to be truncated by the iOS homescreen, so it displays as “Thieme…kshelf” when downloaded.

This sounds like a lot of complaining, but overall we like what Thieme is attempting to do. And it is definitely more convenient to carry around an iPad than three heavy books. If you already have an eBook license from Thieme for multiple books, this free app is worth downloading to your iPad, but the limitations listed above mean that if you only have a small pocket guide, it is more convenient to just carry the physical version. Especially if it is something you want to be able to access quickly and flip through to find relevant info.

Source : http://itunes.apple.com/us/app/thieme-bookshelf/id509171227

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