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.
Related: Stereotaxis wins updated CE mark for all devices available in Europe
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.”
