Previously Published on NewsWire.com — Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses – which means…
Today Beta Bionics was granted FDA breakthrough device designation for the iLet bionic pancreas system. The designation was granted in all configurations of the iLet (insulin-only, glucagon-only and bihormonal). The meaning of FDA breakthrough device designation is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review….
I’ve been touting the bionic pancreas called “The iLet” from Beta Bionics for a while now and it’s launch is almost here. The iLet is an autonomous insulin delivery system that uses an insulin pump with a CGM. I’m currently using the Medtronic 670g system for my treatment but it’s far from perfect for me….