Fujifilm introduced as we speak that the FDA granted 510(ok) clearance for its CAD EYE AI-powered detection system for endoscopic imaging.
CAD EYE allows the real-time detection of colonic mucosal lesions like polyps and adenomas throughout colonoscopy procedures. It helps endoscopists in detecting and eradicating pre-cancerous lesions, no matter dimension, form and coloration. The system enters a market presently cornered by Medtronic and its GI Genius system.
GI Genius, a computer-aided polyp detection system powered by AI, first turned obtainable within the U.S. in 2021. Learn extra about Medtronic’s AI-related efforts for GI Genius right here.
Fujifilm’s system encompasses a suitable growth unit (the Fujifilm EX-1) and endoscopy assist software program (EW10-EC02). CAD Eye builds upon the corporate’s Eluxeo endoscopic imaging system, with AI picture processing for integration with the system’s processor and endoscope.
The corporate plans to make CAD EYE commercially obtainable this spring after it completes a restricted market analysis.
“Daily we delight ourselves on delivering what we consider is the best high quality imaging and optics, arming endoscopists with the instruments they should fight this public well being concern,” stated Tai Fujita, GM, endoscopy, Fujifilm Healthcare Americas Company. “At present, we’re thrilled to take {that a} step additional with the introduction of CAD EYE, which has the potential to dramatically enhance the standard of colonoscopy.”
Extra concerning the Fujifilm CAD EYE system
The corporate developed CAD EYE utilizing deep studying know-how in its Tokyo-based international AI know-how middle. Fujifilm validated the system utilizing histologically confirmed polyps in medical pictures.
CAD EYE works with each white gentle imaging and Linked Coloration Imaging (LCI). Fujifilm included an enhanced visualization mode to distinguish the crimson coloration spectrum, enhancing mucosal visualization.
In line with a information launch, the know-how helps the detection of lesions that might show simple to overlook. This consists of flat lesions, these on the nook of the endoscopic view and a number of lesions current in a single body. When CAD EYE identifies a suspicious polyp, the doctor mechanically receives each visible and auditory alerts. Visible cues overlay, however don’t intrude with the medical pictures throughout the present workflow.
Fujifilm stated research demonstrated CAD EYE’s capability to result in appreciable advances in colorectal most cancers detection and analysis. The system detects considerably extra adenomas throughout screening and surveillance in comparison with typical high-definition colonoscopy with out AI help. Plus, that happens with none improve in process time.
Moreover, Fujifilm noticed 17% increased adenoma per colonoscopy when in comparison with high-definition typical colonoscopy. The system detects colorectal neoplastic lesions at a degree akin to that of an professional and superior to that of a newbie, the corporate stated.
“As a gastroenterologist devoted to affected person care and security, I’m heartened by the FDA’s approval of Fujifilm’s AI CAD polyp detection algorithm. This breakthrough not solely allows the early detection of precancerous lesions that may lead as much as colorectal most cancers but additionally considerably reduces the chance of missed lesions, enhancing our precision and bettering affected person outcomes,” stated DR. Sravanthi Parasa of the Swedish Medical Heart. “It marks a pivotal development in our capability to safeguard affected person well being, reinforcing our dedication to embracing technological improvements in gastrointestinal healthcare.”