It is quite possibly a new era in blood glucose monitoring! This morning, the FDA approved Sanofi-Aventis' groundbreaking iBGStar product, the first and only BG meter that connects directly to your Apple iPhone or iPod touch. No cables are necessary, as this little meter sports an Apple-compatible plug built right in!
The iBGStar is already available in Germany, France, Switzerland, the Netherlands and Italy — and I am one of the first lucky U.S. patients to have my hands on one, as the developers provided me a review unit a few months ago. It truly is revolutionary to see your smartphone transform into a device that physically impacts your health.
There's no word yet on how long it will take for iBGStar to actually go on sale here, but the company just made the U.S. website for iBGStar live this morning, complete with a cute little commercial video and product details. Check it out at www.ibgstar.us. You can sign up for updates.
"This is a momentous occasion," gushed Shawna Gvazdauskas, Vice President and Head of Devices of Sanofi's US Diabetes division over the phone today. "Obviously we're as excited as you are, but I can't disclose any details at this early stage. We're not issuing any statements yet, but I can say that a 'generic' announcement was made at the mHealth conference (in Washington, DC) today."
The FDA approving a medical device that plugs directly into a smartphone — and a consumer communication platform — is indeed groundbreaking. This paves the way for all sorts of phone/mobile/medical innovations.
So will the iBGStar and accessories like cases actually be sold in Apple stores around the country? Shawna couldn't say. "That's still up in the air. We're working on commercialization strategies," she told me.
I for one am very excited and VERY ENCOURAGED by this development; perhaps FDA is not as paralyzed on medical device innovation and technology integrations as they've appeared to be! This bodes well for all things diabetes, I believe.
Ever devil's advocate, industry analyst David Kliff of Diabetic Investor (who alerted us to the news) takes a more measured approach:
"With this approval we'll finally see if iPhone users who also have diabetes will favor a meter that works with their phone or will they remain loyal to their existing monitor. Although the iPhone is wildly popular and the iBGStar will certainly have the 'cool' factor, this does not solve some of the fundamental dynamics of the BGM market. Sanofi still must get the system on formulary and make the cost on par with existing systems. While there will a sub-segment of the market that will pay for the iBGStar, after all people have been known to stand in line for hours waiting for the latest version of the iPhone, the iBGStar as cool as it is just a glucose monitor."
Yup. I can just see some of you running for your lawn chairs now — getting ready to camp out in front of the iBGStar store!