Tidepool Loop automated insulin delivery system wins FDA clearance

Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system.

Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors.

The company announced collaborations in the past that include pumps from Insulet and Medtronic. However, it has not yet announced its initial launch device partners. It currently has a development partnership with Dexcom and additional yet-to-be-named medical device companies.

In a blog post on the company’s website last month, Howard Look, Tidepool’s founder, president and CEO, confirmed the FDA clearance.

“What we submitted was different from other [AID] solutions on the market, because our submission did not depend on proprietary insulin pump or continuous glucose monitoring hardware that we develop or control,” Look wrote. “Instead, we submitted Tidepool Loop as a fully interoperable solution for diabetes management. Giving people living with diabetes the freedom and flexibility to collaborate with their healthcare providers, to select the interoperable hardware components, and to establish the settings configurations that work best for their particular situation is part of our bigger goal. FDA clearance is a critical milestone in that roadmap.” Drug Delivery Business