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US Food and Drug Administration approves artificial pancreas system
An artificial pancreas developed by researchers at the University of Cambridge has been granted approval by the U.S. Food and Drug Administration (FDA) for use by individuals with type 1 diabetes aged 2 and older, including during pregnancy.
This means that even more people living with the disease will be able to use this life-changing app. For the first time, the FDA authorized the use of the artificial pancreas system in pregnancy.
CamAPS FX, produced by Cambridge spinout company CamDiab, is an Android app that can be used to help manage glucose levels in people with type 1 diabetes, 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 was given FDA authorization on Thursday 23 May. 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 Pediatrics 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."
CamAPS FX is already used by more than 27,000 people in 15 countries across Europe and Australia. Artificial pancreas systems such as CamAPS FX have been granted approval for wide use by the NHS in November 2023 by the National Institute for Health and Care Excellence (NICE).
