CamDiab Wins FDA Nod for Hybrid Closed-Loop Insulin Delivery App

CamDiab has earned U.S. Food and Drug Administration (FDA) authorization for its CamAPS FX adaptive, hybrid closed-loop app as an interoperable glycemic controller device (iAGC).
 
The Android app helps manage glucose levels in patients with type 1 diabetes age two and older, including during pregnancy. According to the company, it’s known as the world’s first artificial pancreas app.
 
The CamAPS FX app lets a compatible insulin pump and continuous glucose monitor (CGM) “speak” to each other and create an “artificial pancreas.” The closed-loop algorithm was extensively tested in clinical trials, CamDiab said. It’s already CE-marked for use in the UK and 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.
 
“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,” he 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.”
 
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.