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Home » Portal Diabetes earns FDA breakthrough nod for implantable insulin pump

Portal Diabetes earns FDA breakthrough nod for implantable insulin pump

February 17, 2026 By Sean Whooley

Portal Diabetes Portal Pump implantable insulin pump
The Portal Pump, an implantable system for closed-loop insulin delivery. [Image from Portal Diabetes]
Portal Diabetes announced today that it received FDA breakthrough device designation for its implantable insulin pump system.

Our sister site, Drug Delivery Business News, reports today that the Westfield, Indiana-based company can now begin a Phase 1 study to evaluate its proprietary, temperature-stable insulin. It aims to deliver a functional cure for type 1 diabetes.

Currently, externally-worn insulin pumps like Insulet’s Omnipod 5, Medtronic’s MiniMed 780G, Tandem Diabetes Care’s t:slim X2 and Mobi and Beta Bionics’ iLet lead the way. These devices utilize closed-loop capabilities, although they have programmable and hybrid settings to manage insulin delivery. Insulet has a fully closed-loop system under development, while iLet aims to serve as a closed-loop “bionic pancreas” as well.

An implantable system from Portal Diabetes would mark a first on the U.S. market.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Diabetes, Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Health Technology, Implants, Patient Monitoring, Regulatory/Compliance Tagged With: FDA, Portal Diabetes

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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