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FDA authorises CamDiab’s CamAPS FX artificial pancreas app

The US Food and Drug Administration (FDA) has granted authorisation for CamDiab’s adaptive hybrid closed-loop CamAPS FX app, marking a significant milestone in diabetes care technology.

The artificial pancreas app, which functions as an ‘interoperable automated glycaemic controller device’ (iAGC), is designed to automatically adjust insulin delivery based on sensor glucose readings. This approach will provide a solution for individuals with type 1 diabetes.

The CamAPS FX app, available on Android, is claimed to be the world’s first artificial pancreas app.

It facilitates the management of glucose levels for people with type 1 diabetes from the age of two years, including those who are pregnant.

By enabling communication between a compatible insulin pump and continuous glucose monitor, the app effectively creates an artificial pancreas system.

With over 27,000 users in 15 countries, CamAPS FX has demonstrated a global impact on diabetes management.

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It is available in regions including Austria, Australia, Belgium, the Czech Republic, Finland, France, Germany, Ireland, the Netherlands, Poland, Norway, Spain, Sweden, Switzerland, and the UK.

Plans are on to expand the app to additional countries.

CamAPS FX creator and University of Cambridge Institute of Metabolic Science and Department of Paediatrics Metabolic Technology professor Roman Hovorka said: “We set out to help people with type 1 diabetes and their families live better lives and we’re delighted that the FDA has reviewed the safety and effectiveness of CamAPS FX and has given the technology its approval.

“It has been extensively tested and we’re proud that it is considered by many to be the best algorithm out there.

“Randomised 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.”

In April 2022, CamDiab entered a partnership with Abbott, and Ypsomed  to develop and market an integrated automated insulin delivery (AID) system to help patients manage their diabetes round-the-clock.

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