The iBGStar blood glucose monitoring system is the first glucose meter 510(k)-cleared to connect directly to an Apple iPhone or iPad, Sanofi U.S. and partner AgaMatrix announced Dec. 7. (See Also see "Medical Device Apps On Mobile Handsets Require Cross-Industry Partnerships" - Medtech Insight, 4 May, 2009..) The glucose meter can be used with the iBGStar Diabetes Manager App, which allows users to send data through emails to clinicians and is available for free at the Apple App Store. Last year, AgaMatrix signed a deal to develop a line of blood glucose monitors exclusively for Sanofi-Aventis, which agreed to market the devices alongside its existing diabetes care products. (See [A#01360140022_b].)
FDA Chief Scientist and CDRH Deputy Director William Maisel spotlighted the device’s FDA clearance during the mHealth Summit in National Harbor, Md., Dec. 7. Speaking of the overall mobile health...
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