Our patient community has been up in arms for quite some time about glucose meter accuracy, or rather lack thereof. Fortunately, the patient-initiated StripSafely campaign seems to have struck a chord, and the FDA has recently — at long last — issued new “draft guidance” on accuracy standards. What surprised a lot of people, though, is how FDA chose to split their recommendations into two categories: one set of requirements for meters purchased over-the-counter and…Read more »
Well, we’ve all made it through another year!
Amazing that it’s almost time to turn the page on 2013 and move into 2014… With about a week left, we are about 98% sure we can say that all the big diabetes news of this year has probably materialized already.
There have been some exciting steps forward on long-awaited product developments, from FDA filings to approvals that the Diabetes Community has been anticipating. Not to mention…
John Brooks III is CEO of the legendary Joslin Diabetes Center in Boston. He’s unique as the leader of an academic medical center, in that he has a strong background in industry — having previously co-founded Insulet (makers of the OmniPod) and two other life sciences companies. We interviewed him in Spring about his ambitious plans to spread Joslin’s expertise across the country and around the world. It’s all about utilizing tech innovations in the…Read more »
On Friday, Nov. 15, we gathered with about 120 people at Stanford School of Medicine for the 2013 DiabetesMine Innovation Summit — a small-ish gathering designed to spark interactions and discussions that lead to faster, better development and design, and improved access to innovations that will improve life with diabetes. That was a long-winded way of saying: it’s all about new and better ways to improve life with diabetes.
This is the third annual gathering…
Big news in the mobile health world! The FDA approved final guidelines earlier this week on what is considered a “mobile medical app” and needs U.S. regulatory approval.
These much-anticipated mHealth guidelines come a full 27 months after the FDA issued draft guidelines and welcomed public comment, meaning the agency has spent a little over two years compiling extensive examples and finalizing the document for public release.
Being huge medical-mobile-health enthusiasts ourselves, we were excited…