Tidepool Loop is the first fully interoperable automated insulin dosing app, cleared by the FDA, that originated as a patient-led initiative. Born fro

Groundbreaking: Tidepool Loop receives FDA clearance

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2023-01-25 02:30:12

Tidepool Loop is the first fully interoperable automated insulin dosing app, cleared by the FDA, that originated as a patient-led initiative.

Born from the #WeAreNotWaiting community of innovators, Tidepool Loop is the first automated insulin dosing app cleared to enable control from a compatible Apple Watch.

With Tidepool Loop, we are reimagining how people with diabetes can get started with automated insulin dosing, how to ask for help when needed, and how to fit control, discretion, and flexibility into your diabetes management.

Tidepool Loop is an app designed to automate your insulin dosing, intended for the management of type 1 diabetes in people with diabetes six years of age or older.

What if there was a world where anyone with diabetes and a smartphone might access the latest innovations coming from medtech, with the flexibility to choose the components they believe reduce their diabetes burden in the most meaningful way to them? That’s the promise of interoperability.

The US FDA has created new pathways for components (and the companies that make them) to work together so that users might one day have more choices in the systems they use. They’ve determined three types of components and a regulatory pathway for each:

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