This morning on the last day of the mHealth Summit, Dr. William Maisel, the deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health told attendees that today the FDA had cleared the first iPhone glucose meter. Maisel made the comment off-handedly, according to MobiHealthNews contributing editor Neil Versel, who was in attendance. Maisel also did not name the device or the company behind it.
In an email to MobiHealthNews, a representative from Sanofi confirmed that the iBGStar was the iPhone glucose meter that Maisel had referenced and that the device now has FDA 510(k) clearance. While AgaMatrix manufactured the device, Sanofi submitted and received clearance for the iBGStar from the FDA, a spokesperson for Sanofi said.
Sanofi has long planned to sell the iBGStar in the United States. It began offering the device in Europe earlier this year. In Europe it is currently available in Germany, France, Switzerland, the Netherlands and Italy.
“iBGStar is the first available blood glucose meter that seamlessly connects to the iPhone and iPod touch allowing you to view and analyse accurate, reliable information in ‘real time,’” Sanofi Aventis stated in September 2010 on the website for the device. “Using the technology built into your iPhone or iPod touch, you can share this information with your healthcare professional while on-the-go, to help you make better-informed diabetes-related decisions together.” At the time AgaMatrix had expected the device to become commercially available in the US in either January or February of this year. Instead, the companies have waited an additional 11 months as the FDA put the device through its regulatory ringer.
Similarly, iPhone imaging app developer MIM had to wait about two years for the FDA to clear its diagnostic medical app, Mobile MIM. In February of this year, MIM’s app became the first diagnostic imaging app to receive FDA clearance.
As of this writing the iPhone companion app for the iBGStar device is not yet available on the Apple AppStore.
Here’s how Sanofi describes the app: “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.”
MobiHealthNews’ coverage of the mHealth Summit is brought you by Preventice.
UPDATED: Sanofi has officially announced the FDA’s clearance of the device now – read the official announcement here. Removed references to the device as also being known as the “Nugget” after receiving word from Sanofi that the device will be marketed as the “iBGStar” in the United States.