Sanofi U.S., together with its partner AgaMatrix, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) premarket clearance for the 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 integrating accurate blood glucose monitoring into the lifestyles of people with diabetes. The iBGStar™ is already available in Germany, France, Switzerland, the Netherlands and Italy.
The compact iBGStar™ glucose meter, when plugged directly into the iPhone® or iPod® touch, quickly displays results immediately after testing on the full-color touch screen via the iBGStar™ Diabetes Manager App. iBGStar™ also can be used alone to measure blood glucose levels and results can be synchronized to an iPhone® or iPod® touch at a later time.
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 can be downloaded for free from the App Store.
The iBGStar™ uses patented Dynamic Electrochemistry®1 technology that provides accurate results by helping to detect and correct for errors caused by differences in hematocrit 2 levels, manufacturing variations and certain environmental conditions.
Further information is available at www.ibgstar.us.
In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring (BGM) solutions. iBGStar™ is among the first products of this agreement.
The iBGStar™ received the red dot design award 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 the year 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.
Dynamic Electrochemistry® is a trademark of AgaMatrix Inc., registered in the United States and other countries.
Source: Sanofi Meidia Room
Date: 7 December 2011
URL: http://sanofi.mediaroom.com/index.php?s=64&item=57