Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study

17 Feb 2026


National

Portal Diabetes, Inc. ("Portal") announced its receipt of the Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable insulin pump system called "Portal Pump," and the start of a Phase 1 study on its proprietary temperature-stable insulin ("Portal Insulin").

The Westfield, Indiana company aims to deliver a functional cure to type 1 diabetes-- an implantable insulin pump leveraging the physiologic delivery of insulin to the abdomen, modern continuous glucose monitoring (CGM) technology, and stable, concentrated insulin to fully close the loop on insulin delivery for patients living with type 1 diabetes.

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