FujiFilm Receives FDA Clearance for CAD EYE® AI-Powered Endoscopic Imaging System for Colonic Polyp Detection

FUJIFILM Healthcare Americas has received the US FDA 510(k) clearance for CAD EYE, its novel AI detection system for endoscopic imaging that enables real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, helping endoscopists detect and remove pre-cancerous lesions regardless of size, shape and color.

Consisting of Fujifilm EX-1 compatible expansion unit and EW10-EC02 endoscopy support software, CAD EYE is an evolution of Fujifilm’s ELUXEO® Endoscopic Imaging System, featuring AI image processing functionality customized for the integration with the system’s processor and the endoscope. It was developed at Fujifilm’s global AI technology center in Tokyo to support the detection of lesions that are most easily missed, such as flat lesions, those in the corner of the endoscopic view and multiple lesions in a single image.

This breakthrough not only enables the early detection of precancerous lesions that can lead up to colorectal cancer but also significantly reduces the risk of missed lesions, enhancing our precision and improving patient outcomes. It marks a pivotal advancement in our ability to safeguard patient health, reinforcing our commitment to embracing technological innovations in gastrointestinal healthcare,” said Sravanthi Parasa MD FASGE, Gastroenterology at Swedish Medical Center.

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