Fujifilm Wins FDA Nod for AI-Powered Colonic Polyp Detection
The FDA has granted Fujifilm Healthcare Americas 510(k) approval for their endoscopic imaging CAD EYE artificial intelligence (AI) detection devices. During colonoscopies, these devices allow for the real-time detection of mucosal lesions of the colon, such as adenomas and polyps. The EW10-ECO2 endoscopic software and the extension device compatible with the Fujifilm EX-1 make up the system. A development of the company's ELUXEO endoscopic imaging, CAD EYE has AI image processing that is tailored to work with the endoscope and processor of the system. Deep learning was used in Fujifilm's AI technology center in Tokyo to build the technology, which was then verified in studies with histologically verified polyps in photos taken from Fujifilm endoscopic systems. Lesions that are most likely to go unnoticed include those that are flat, located in the corner of the endoscopic view, and present in several frames. These lesions are targeted for detection by CAD EYE. When a suspicious polyp is discovered, doctors receive both visual and aural signals; in the current workflow, visual images are superimposed on clinical images. Research has demonstrated that, without extending the duration of the operation, CAD EYE detects more adenomas during screening and monitoring than high-definition colonoscopy performed without AI support. Both linked color imaging (LCI) and white light imaging can be utilized with this device.
