Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system.
The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market the system, which is cleared for people ages six and up with type 1 diabetes.
Sequel CEO and co-founder Dr. Alan Lotvin said clearance marks “a pivotal first step” on the company’s mission. The company expects to distribute the system through the pharmacy channel as well. That should offer a convenient, affordable way to start on an AID system, Lotvin said.
Get the full story at our sister site, Drug Delivery Business News.