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….
Beta Bionics announced a pivotal bihormonal iLet home trial using both dasiglucagon and insulin in the aforementioned bionic pancreas. The iLet (dual-hormone pump system) designed to autonomously deliver insulin and dasiglucagon. The bionic pancreas offers people with type 1 diabetes, safer and easier blood sugar control. Therefore, better long-term management and outcomes are possible as well. What is…
Bionic Pancreas Critical Hurdle! Beta Bionics recently won $12 million in supplemental funding from the National Institutes of Health (NIH) to conduct a major multicenter, national clinical trials for the iLet™ (bionic pancreas). Developed by Edward Damiano (Beta Bionics) and Firas El-Khatib. They hope to have the device approved for market in about a year….
The Bionic Pancreas called “iLet” by Beta Bionics. The only fully integrated, fully automated, bihormonal bionic pancreas. The device uses both, insulin to lower blood sugar and glucagon to raise blood sugar for optimal glycemic control, a bridge to a cure. As I write this, the pump device is not yet available to the public. A…