Fujifilm Receives FDA Approval for AI-Powered Endoscopy Technology, Potentially Challenging Medtronic’s GI Genius

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In a recent announcement, Fujifilm revealed that its CAD EYE AI-powered detection system for endoscopic imaging has received 510(k) clearance from the FDA. This system is designed to facilitate real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures. It aims to assist endoscopists in identifying and removing pre-cancerous lesions, irrespective of their size, shape, or color. With this clearance, Fujifilm enters a market currently dominated by Medtronic and its GI Genius system.

Fujifilm Cad Eye AI powered endoscopy (Image Courtesy: FujiFilim)
Fujifilm Cad Eye AI powered endoscopy (Image Courtesy: FujiFilim)

Medtronic’s GI Genius, an AI-powered polyp detection system, has been available in the U.S. since 2021. Fujifilm’s CAD EYE system, however, introduces a new competitor into the field. The CAD EYE system comprises a compatible expansion unit (the Fujifilm EX-1) and endoscopy support software (EW10-EC02). It integrates AI image processing with Fujifilm’s Eluxeo endoscopic imaging system, offering enhanced capabilities for endoscopic procedures.

Fujifilm plans to launch CAD EYE commercially this spring following a limited market evaluation. Tai Fujita, General Manager of Endoscopy at Fujifilm Healthcare Americas Corporation, expressed excitement about the potential of CAD EYE to enhance the quality of colonoscopy procedures. He emphasized the company’s commitment to providing high-quality imaging tools to support healthcare professionals in addressing public health challenges.

The CAD EYE system was developed using deep learning technology at Fujifilm’s global AI technology center in Tokyo. The company validated the system using histologically confirmed polyps in clinical images. CAD EYE is compatible with both white light imaging and Linked Color Imaging (LCI). It includes an enhanced visualization mode to improve mucosal visualization, particularly in differentiating the red color spectrum.

According to Fujifilm, CAD EYE can detect lesions that may be easily overlooked, including flat lesions and those at the edge of the endoscopic view. The system provides visual and auditory alerts to physicians when suspicious polyps are detected, without disrupting the existing workflow. Clinical studies have shown that CAD EYE leads to significant improvements in colorectal cancer detection and diagnosis, detecting more adenomas during screening and surveillance compared to conventional high-definition colonoscopy without AI assistance.

Dr. Sravanthi Parasa of the Swedish Medical Center praised the FDA’s approval of Fujifilm’s AI CAD polyp detection algorithm. He emphasized the potential of this technology to enable early detection of precancerous lesions and reduce the risk of missed lesions, thereby improving patient outcomes. The approval marks a significant advancement in gastrointestinal healthcare, reinforcing the importance of embracing technological innovations in patient care and safety.

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