AgaMatrix Receives U.S. FDA 510(k) Clearance for iPhone®-based Diabetes Product
Salem, New Hampshire, December 13, 2011 AgaMatrix, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) premarket clearance for the iBGStar™ Blood Glucose Monitoring System. This product will be marketed and sold in the United States by its distribution partner Sanofi U.S., one of the world’s largest pharmaceutical companies. The iBGStar™ is the first and only blood glucose meter (BGM) that is FDA-cleared for use with Apple’s (NASDAQ: APPL) iPhone® and iPod touch® devices.
“We are seeing smartphones and mobile services disrupt communication, commerce, entertainment, and almost every other facet of modern life,” said Katie Rae, managing director of TechStars Boston, one of the largest tech accelerator programs. “Healthcare has lagged behind on leveraging smartphones, but AgaMatrix’s product illustrates where this industry is headed and how information and connectivity can improve the lives of patients.”
The iBGStar™ works with the iBGStar Diabetes Manager App (iBGStar DMA) and allows people with diabetes to accurately monitor their blood glucose, analyze and track their data, and share their readings with healthcare professionals or caregivers. Currently, the iBGStar™ system works exclusively with Apple’s iOS platform. The iBGStar DMA is available on the iTunes App Store™.
“We’re proud that the FDA has cleared the iBGStar™ and feel that it demonstrates their commitment to innovation in medical devices. This marks an important step towards bridging mobile platforms and healthcare solutions,” said Dr. Sridhar Iyengar, AgaMatrix’s Co-Founder and Chief Technology Officer. “Now, millions more people with diabetes can use this device as part of their daily diabetes management.”
For more information, see http://www.ibgstar.us.
AgaMatrix is a private company based in Salem, New Hampshire, that invents, develops, manufactures, and markets a line of blood glucose meters, biosensors (strips), and diabetes management software. AgaMatrix’s products are designed to improve the quality of diabetes care by using the company’s proprietary WaveSense™ technology to personalize each test to provide world class accuracy. The technology employs a new detection method called Dynamic Electrochemistry® to detect and correct for many errors caused by differences in blood samples and environmental conditions. Current AgaMatrix products include the KeyNote®, Presto®, and WaveSense Jazz® BGMs, and the WaveSense Diabetes Manager™ iPhone® App. AgaMatrix’s WaveSense™ line of meters and strips are covered by insurance and are available by mail order and at popular retail outlets. For more product information, go to: http://www.agamatrix.com.
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, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
© 2002-2011 AgaMatrix, Inc. AgaMatrix, WaveSense, Dynamic Electrochemistry, KeyNote, Presto, WaveSense Jazz, WaveSense Diabetes Manager are trademarks of AgaMatrix, Inc. iBGStar, Sanofi, Apple, iPhone, iPod touch, iTunes App Store, BGStar, and BGStar Data Management Software are registered trademarks of their respective owners.
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