CamDiab has received authorisation from The Food and Drug Administration (FDA) in the US for its advanced adaptive hybrid closed loop app, CamAPS FX, as an ‘interoperable automated glycaemic controller device’ (iAGC).
The Android app – known as the world’s first artificial pancreas app – 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 a compatible continuous glucose monitor to ‘talk to each other’, creating an artificial pancreas.
The CamAPS FX closed loop algorithm has been extensively tested in clinical trials and prior to the FDA authorisation on Thursday, May 23, it had already been CE-marked for use in the UK and the EU.
CamAPS FX creator Roman Hovorka is Professor of Metabolic Technology at the Institute of Metabolic Science and Department of Paediatrics at the University of Cambridge, where the technology was developed.
He 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 well-being.”
CamAPS FX is available in Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland and the UK and more countries are in the pipeline.
For further information about CamDiab and CamAPS FX, visit https://camdiab.com/