Sequel Med Tech today announced that its partner DEKA R&D has received FDA 510(k) clearance for its automated insulin dosing (AID) system.
The Tidepool-powered Twist system directly measures the amount and flow rate of insulin delivered with each microdose. Provides functionality and flexibility to meet each patient’s individualized dosing needs. Sequel plans to market the system approved for patients with type 1 diabetes who are 6 years of age and older.
Dr. Alan Lotvin, CEO and co-founder of Sequel, said the approval marks a “vital first step” in the company’s mission. The company expects to distribute the system through pharmacy channels as well. This should provide a convenient and affordable way to get started with an AID system, Lotvin said.
“Sequel is committed to simplifying life with diabetes by introducing product and process innovations while expanding access to everyone,” said Lotvin. “As we get closer to launch, we will share further details about additional initiatives designed to expand access and simplify the patient experience.”
Learn more about the Sequel twist system
Sequel designed the twiist AID system to take advantage of FDA medical device interoperability standards. The company says this will allow patients to tailor their insulin therapy to their own needs. Incorporating Tidepool Loop technology allows automatic adjustment of insulin dosing based on CGM readings and predicted blood glucose levels.
Tidepool’s FDA-cleared hybrid closed-loop AID app works with multiple insulin pumps and CGMs. The company is working with several companies on automated insulin dosing, including Envector and Medtronic.
Tidepool President and CEO Howard Look said Twist “represents significant progress.” DEKA R&D developed the underlying drug delivery technology.
Dean Kamen, co-founder of Sequela and founder of DEKA, the first to commercialize a wearable insulin pump for diabetes, says the system “represents the next generation of insulin delivery.”
“The Twist AID system reimagines the way insulin is measured and administered, making it more personalized with a simpler design,” said Kamen. “We believe the Twist AID system will set a new standard for accurate and reliable insulin delivery in the future.”
