FDA names Beta Bionics’ pancreas tech a breakthrough device

This is SUPER cool! Good job Beta Bionics!

Dive Brief:

Boston-based medtech Beta Bionics said Tuesday it received priority review from FDA as part of the Breakthrough Devices Program for its​ iLet system​, which uses mathematical dosing algorithms to automatically control blood sugar levels in people with diabetes.
The technology, which the company calls a bionic pancreas, can be configured in three ways: for insulin-only, glucagon-only for certain rare conditions, or bihormonal use, the company said.
Beta Bionics has said it plans to start a Phase 3 pivotal trial for the latter version of the system in 2020.

Dive Insight:

Beta Bionics’ wearable device incorporates autonomous learning to automatically control blood sugar. It is worn on the body like an insulin pump, but differs in that a patient needs only to enter his or her body weight to initialize the system, without counting carbohydrates, setting insulin delivery rates, or using bolus insulin for meals, the company said.

The company was founded in 2015 by parents of children with Type 1 diabetes. The dosing algorithms were developed at Boston University in the lab of CEO Ed Damiano and refined through results from home-use clinical trials in adults and children with Type 1 diabetes.​

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