FDA Grants Clearance to Sequel's twiist™ Automated Insulin Delivery System

19 March 2024

Sequel Med Tech, a company at the forefront of developing advanced insulin delivery solutions, has announced a major achievement in partnership with DEKA Research & Development Corp. The twiist™ Automated Insulin Delivery (AID) system, powered by Tidepool and developed in collaboration with DEKA, has obtained FDA 510(k) clearance. This innovative system is the first of its kind, capable of directly measuring insulin volume and flow with every micro-dose.

Tailored for individuals aged 6 and above with type 1 diabetes, the twiist AID system, to be marketed by Sequel Med Tech, LLC, offers unmatched flexibility and customization to suit each patient's unique dosing needs. AID systems like twiist integrate data from continuous glucose monitoring (CGM) devices, control algorithms, and insulin pumps to automate insulin delivery, empowering patients to manage their blood sugar levels more effectively.

The twiist AID system utilizes FDA medical device interoperability standards, allowing patients to personalize their treatments according to their specific requirements. This clearance represents a significant step forward in Sequel's commitment to enhancing the daily lives of individuals with type 1 diabetes, providing precise insulin delivery and greater control over their condition.

Integrating FDA-cleared Tidepool Loop technology, the twiist system enables automatic adjustments to insulin delivery based on CGM readings and predicted glucose levels. Sequel's collaboration with Tidepool, a diabetes-focused non-profit organization, ensures that the technology is community-driven, customizable, and clinically effective, meeting the diverse needs of patients.

With its innovative design and focus on personalization, the twiist AID system revolutionizes insulin measurement and delivery, simplifying the management of type 1 diabetes. This advancement holds promise for the millions of Americans living with this lifelong condition, offering new avenues for improved health and well-being.

Source: globenewswire.com