FDA allows automatic sorting of endoscopic capsule images for small intestine bleeding

AI Highlights, CapsoVision's tool, tracks suspicious images in CapsoCam Plus recordings and takes them back to the doctor first.

On September 25, CapsoVision obtained the US marketing authorisation from AI Highlights, a rereading aid module integrated with its CapsoCam Plus endoscopic capsule system. It is intended for small intestine examinations in adults and children over two years of age if bleeding is suspected.

The principle is that of sorting: the capsule swallowed by the patient produces a very large number of images during its transit, and the algorithm analyses these views at the time of video treatment to report those that contain a suspected injury. The doctor keeps the decision, but starts rereading with the marked sequences, which aims to reduce a long and repetitive task. The module fits into CapsoView, the company's processing and reading software, and works with the CapsoCloud platform.

The tool was already circulating outside the United States, particularly in the European Union under the Medical Devices Regulation; This authorization opens the US market. The context is one of increasing regulatory congestion: the FDA has now authorized more than 1,600 AI-integrated medical devices.