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FDA approves hybrid closed-loop insulin delivery app from CamDiab

May 24, 2024 By Sean Whooley

CamDiab CamAPS FX
The CamAPS FX app. [Image from CamDiab]
CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.

CamAPS FX, an Android app, received approval as an interoperable automated glycemic controller device (iAGC). It helps to manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy.

The app allows a compatible insulin pump and compatible continuous glucose monitor (CGM) to speak to one another, creating an artificial pancreas. CamAPS FX already went through extensive clinical trial testing and holds CE mark for use in Europe and the UK. It features integration capabilities with the Dexcom G6 and the FreeStyle Libre 3 — Abbott’s newest sensor — to work with the Ypsomed mylife YpsoPump.

Altogether, CamAPS FX now has availability in Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland and the UK. CamDiab said it has more countries in the pipeline as well.

Roman Hovorka created CamAPS FX and developed it at the University of Cambridge. Hovorka now serves as a professor of metabolic technology at Cambridge’s Institute of Metabolic Science and Dept. of Pediatrics. He said the company set out to help people with type 1 diabetes and their families live better lives.

“We’re delighted that the FDA has reviewed the safety and effectiveness of CamAPS FX and has given the technology its approval,” Hovorka said. “It has been extensively tested and we’re proud that it is considered by many to be the best algorithm out there. Randomized clinical trials have shown a significant increase in time in range and a reduction in HbA1c without increasing the risk of low glucose levels, and improved wellbeing.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: CamDiab, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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