Saturday, May 25, 2024
CamDiab has received approval from the Food and Drug Administration (FDA) in the US for its innovative adaptive hybrid closed-loop app, CamAPS FX, designated as an ‘interoperable automated glycaemic controller device’ (iAGC).
This Android application, recognized as the world's first artificial pancreas app, aids in managing glucose levels for individuals aged two and above with type 1 diabetes, including pregnant women.
The app enables seamless communication between a compatible insulin pump and continuous glucose monitor, effectively mimicking the function of a natural pancreas.
Developed by Professor Roman Hovorka, who serves as the Professor of Metabolic Technology at the University of Cambridge's Institute of Metabolic Science and Department of Paediatrics, the CamAPS FX closed-loop algorithm underwent thorough clinical trials and had previously obtained CE marking for use in the UK and the EU before receiving FDA authorization on Thursday, May 23.
Professor Hovorka expressed his satisfaction with the FDA's approval, highlighting the team's goal of improving the lives of individuals with type 1 diabetes and their families.
He emphasized the extensive testing undergone by CamAPS FX and its recognition as a leading algorithm.
Randomized clinical trials have demonstrated significant enhancements in time spent within the target glucose range, reductions in HbA1c levels, and overall improved well-being.
Currently available in several countries, including Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, and Switzerland, CamAPS FX is poised for further expansion into additional markets.
Source: camdiab.com
