FDA Clears twiist Automated Insulin Delivery System for Patients With Type 1 Diabetes

The Food and Drug Administration (FDA) has granted 510(k) clearance to twiist™ Automated Insulin Delivery (AID) system for individuals 6 years of age and older with type 1 diabetes.

The twiist AID system is designed to directly measure the volume and flow of insulin with every micro-dose, and address an individual’s dosing needs. The system integrates data from a continuous glucose monitoring (CGM) device, a control algorithm, and an insulin pump to automate insulin delivery and manage blood sugar levels. 

Using the FDA-cleared Tidepool Loop technology, the twiist AID system is able to automatically adjust insulin delivery according to CGM readings and predicted glucose levels. 

“There’s been a real need for continued innovation in insulin delivery, and the twiist AID system powered by Tidepool represents a substantial leap forward,” said Howard Look, President and CEO of Tidepool. “The twiist AID system takes advantage of the Tidepool Loop algorithm, the first and only FDA-cleared glycemic controller that originated as a patient-led initiative. We are thrilled to see twiist come to market and bring new advancements to people living with type 1 diabetes.”