Beta Bionics Announces FDA Clearance of the iLet Bionic Pancreas

Beta Bionics Announces FDA Clearance of the iLet Bionic Pancreas

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…

The iLet Bionic Pancreas, No Need to Count Carbs

The iLet Bionic Pancreas, No Need to Count Carbs

Previously Published on diaTribe.org – Impressive results from a trial for an up-and-coming artificial pancreas showed that users spent an average of 2.6 more hours in range each day compared to non-users – all without counting carbs. Here’s what trial participants are saying about the new system, The iLet Bionic Pancreas. What is the iLet Bionic Pancreas?…

Bionic Pancreas Removes Math from Diabetes Process

Bionic Pancreas Removes Math from Diabetes Process

Previously Published on medwireNews – The iLet bionic pancreas closed-loop insulin delivery system provides good glucose control without the need for the user to count carbohydrates, show findings from the pivotal trial. Bionic pancreas removes math from diabetes. Instead of counting carbohydrates, users of the Beta Bionics iLet insulin-only bionic pancreas just make meal announcements with the modifier of…

Beta Bionics granted FDA Breakthrough Device Designation for iLet Bionic Pancreas System
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Beta Bionics granted FDA Breakthrough Device Designation for iLet Bionic Pancreas System

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….

bihormonal ilet home trial by Beta Bionics

Bihormonal iLet Home Trial Bionic Pancreas for T1D

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
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Bionic Pancreas Critical Hurdle, iLet

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….