We’ve gotten word that the FDA has approved the exciting Dexcom SHARE system, the first mobile device approval of its kind that allows data from a continuous glucose monitor to be beamed via Bluetooth wireless technology to as many as five smartphones anywhere!
The San Diego-based CGM company Dexcom announced on Monday that it had received FDA approval, 15 months after submitting the device for review in July 2013.
Yes, it’s SHARE with all caps… because we’re not just talking about sharing data by pushing it via email to a doctor somewhere, but rather transmitting it in real time to up to five phones that can be located anywhere in the world.
This approval and the discussions that led up to it are pretty exciting because they appear to be setting the stage for FDA’s approach to reviewing new diabetes mobile tech, and this Dexcom SHARE pathway will incluence how regulators deal with other data-sharing tech — like what Tidepool and Nightscout/CGM in the Cloud developers are working on and discussing with the FDA already.
Some Nightscout proponents are already grumbling that Dexcom SHARE seems to be outdated on arrival, given that thousands of people are already hacking this solution that lets them view their CGM data on any device. But remember, Dexcom SHARE has two major advantages: 1) it is a complete product already, that requires no complicated multi-device setup like Nightscout, and 2) it is an FDA approved product that’s supported by the very company that makes the CGM itself, so users get tech support and safety guarantees, etc.
Detail about Dexcom SHARE first began circulating publicly more than a year ago following an investor relations call, and we were able to publish photos and some details on the product while the D-Community waited for word from the FDA. Dexcom’s clearly been expecting the decision for awhile, because the Dexcom SHARE page went live online as a placeholder in March, offering a welcome area and a variety of links that could be quickly activated once the SHARE was cleared.
You can check out this promotional video explaining the new SHARE. We also found some FCC filings online (required for wireless communication devices), that offer even more detail about how the product will work — everything from cover letters about the new device to pictures of the inside and outside, and even the 88-page user manual.
Based on all of the info available, here’s a rundown of what we know so far: