FDA

FDA approves CamAPS FX, a hybrid closed-loop insulin delivery app

May 29, 2024

CamDiab announced that it had secured clearance on May 24 from the FDA for its advanced adaptive hybrid closed-loop Android app. CamAPS FX is designed to be used with compatible devices for automated insulin dosing in people over aged two with type 1 diabetes. Importantly, the artificial pancreas app is the first of its kind approved for use in pregnant patients with T1D.

CamAPS FX functions as an interoperable automated glycemic controller device (iAGC) and is designed to automatically adjust insulin delivery based on sensor glucose reading. The device features integration capabilities with the Dexcom G6 and Abbot’s newest sensor, the FreeStyle Libre 3.

According to the company’s press release, the device’s closed loop algorithm has been extensively tested in clinical trials that have shown a significant increase in time in range and a reduction in HbA1c without increasing the risk of low glucose levels. Prior to the FDA’s authorization, the device had already secured a CE mark for use in the UK and the EU, and the company plans to expand the app to additional countries.

The app is designed to be compatible with other interoperable devices that meet pre-specified acceptance criteria in a predetermined change control plan provided by the sponsor and cleared by the FDA as part of the premarket submission.

Sources:

(2024, May 24). FDA. FDA roundup: May 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-24-2024.

(2024, May 24). CamDiab. FDA approves CamAPS FX. [Press release]. https://s3.eu-west-1.amazonaws.com/admin.camdiab.com/press.release/CamDiab+secures+FDA+approval+for+advanced+adaptive+hybrid+closed-loop+app+CamAPS+FX.pdf