Drug Topics March 18, 2024
Lauren Biscaldi, MS, Managing Editor

The FDA has granted 510(k) clearance to the twiist Automated Insulin Delivery System, the first drug delivery system that measures both insulin volume and flow with each micro-dose, according to a company press release.1 The system is cleared for use in individuals aged 6 years and older with type 1 diabetes.

The twiist Automated Insulin Delivery System will be commercialized by Sequel Med Tech, LLC; clearance was granted to Sequel’s partner DEKA Research and Development Corp.

Twiist utilizes the FDA’s medical device interoperability standards to help patients more effectively tailor their diabetes management to their individual needs. Specifically, twiist uses FDA-cleared Tidepool Loop technology that allows the automated insulin delivery system to automatically adjust insulin delivery based on continuous glucose...

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Topics: FDA, Govt Agencies, Medical Devices
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