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.
“Sequel is working to simplify living with diabetes by introducing product and process innovation while expanding access for all,” Lotvin said. “As we get closer to launch, we will share more details about additional initiatives designed to expand access and simplify the patient experience.”
More about the Sequel twiist system
Sequel designed its twiist AID system to take advantage of FDA medical device interoperability standards. The company says it helps patients better tailor their insulin therapy to their own unique needs. Incorporating Tidepool Loop technology enables automatic adjustments to insulin delivery based on CGM readings and predicted glucose levels.
Tidepool’s FDA-cleared, hybrid, closed-loop AID app works with multiple insulin pumps and CGMs. It has collaborated with multiple companies on automated insulin delivery, including Embecta and Medtronic.
Howard Look, Tidepool’s president and CEO, said twiist “represents a substantial leap forward.” DEKA R&D developed the underlying drug delivery technology.
Dean Kamen, co-founder of Sequela and founder of DEKA, commercialized the first wearable insulin pump for diabetes, says the system “represents the next generation of insulin delivery.”
“The twiist AID system reimagines how insulin is measured and delivered for more personalization with a simpler design,” Kamen said. “I believe the twiist AID system will set a new standard for precise, dependable insulin delivery going forward.”