Tidepool Loop receives FDA clearance
Tidepool Loop is the first fully interoperable automated insulin dosing app, cleared by the FDA, that originated as a patient-led initiative.
Tidepool Loop™ is commercially available as a licensed and third-party distributed product, most recently by Sequel Med Tech as twiist Loop.
Tidepool Loop™ is commercially available as a licensed and third-party distributed product, most recently by Sequel Med Tech as twiist Loop.
Discretion on your wrist. It’s about time.
First automated insulin dosing app with Apple Watch compatibility
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.
Tidepool Loop is more than an app.
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 patient’s 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.
The first fully interoperable automated insulin dosing system
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 to 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 and prescribers might one day have more choices in the systems they use. They’ve determined three types of components and a regulatory pathway for each:
ACE Pump
"alternate controller-enabled pump"
What that means: the pump is designed to work safely with more than one type of controller or algorithm that adjusts insulin.
iAGC
“interoperable automated glycemic controller”
What that means: The algorithm (computing logic) has been designed to communicate with other compatible diabetes device components in a modular system.
This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.
iCGM
“integrated continuous glucose monitor”
What that means: the CGM system meets FDA’s criteria for accuracy and safety for dosing insulin.
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