MetaMedical™ Solutions Inc

FDA issues 510(k) clearance for twiist insulin system

DEKA Research & Development has received 510(k) clearance from the US Food and Drug Administration (FDA) for the twiist automated insulin delivery (AID) system.

The device is designed to significantly improve insulin management for individuals aged six and above with type 1 diabetes.

Sequel Med Tech will be responsible for commercialising the twiist AID system, which is claimed to be the first drug delivery system to measure the insulin volume and flow with every micro-dose directly.

The device features Tidepool Loop technology, which allows for automatic adjustments in insulin delivery based on continuous glucose monitoring (CGM) readings and predicted glucose levels.

Tidepool Loop is a first fully interoperable automated insulin dosing app cleared by the FDA.

Tidepool president and CEO Howard Look said: “The twiist AID system takes advantage of the Tidepool Loop algorithm, the first and only FDA-cleared glycemic controller that originated as a patient-led initiative. We are thrilled to see twiist come to market and bring new advancements to people living with type 1 diabetes.”

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The device integrates data from a CGM device, a control algorithm, and an insulin pump to help patients manage their blood sugar levels more effectively.

Sequel CEO and co-founder Alan Lotvin said: “The clearance of the twiist AID system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes. The twiist system combines drug delivery technology that directly and precisely measures each dose of insulin, providing the opportunity for better control and flexibility.

“Sequel is working to simplify living with diabetes by introducing product and process innovation while expanding access for all. It’s why we expect to distribute twiist through the pharmacy channel so more people with type 1 diabetes have a convenient, affordable way to get started on an AID system.”

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