Abstract
Sanofi’s iBGStar™ , already available in Germany, France, Switzerland, the Netherlands and Italy has now gained FDA 510(k) premarket clearance in USA. iBGStar™ Blood Glucose Monitoring System, the first and only FDA cleared blood glucose meter that directly connects to the Apple® iPhone® and iPod touch®, seamlessly integrates accurate blood glucose monitoring into the lifestyles of people with diabetes.
Is there really an App for that?
In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring (BGM) solutions and iBGStar™ is among the first products of this agreement. The compact iBGStar™ glucose meter, when plugged directly into an iPhone® or iPod® touch, quickly displays results immediately after testing, on the Apple device’s full-color touch screen via the iBGStar™ Diabetes Manager App. The meter can also be used stand-alone to measure blood glucose levels and results can be synchronized to an iPhone® or iPod® touch at a later time.
Useful features
The iBGStar™ Diabetes Manager App has a range of features that allow users multiple ways to analyze their glucose patterns over time. Patients can record and track readings, carbohydrate intake and insulin doses if taking insulin. Scorecards show individual test results and are color coded so that high and low blood glucose results can be more easily identified. The ‘Share’ function enables users to select specific data to send as an e-mail to their healthcare professional. The application is available as a free download from the App Store.
Source: Sanofi
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.
published: December 12, 2011 in: Approval/Clearance, Regulatory, Technology, USA