Fujifilm Receives FDA Clearance for AI Detection System CAD EYE in Endoscopic Imaging
Fujifilm Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has announced the receipt of 510(k) clearance for CAD EYE, its innovative AI detection system for endoscopic imaging. CAD EYE is designed to facilitate real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, aiding endoscopists in identifying and removing pre-cancerous lesions.
CAD EYE comprises a compatible expansion unit (the Fujifilm EX-1) and endoscopy support software (EW10-EC02), serving as an extension of Fujifilm’s ELUXEO Endoscopic Imaging System. Developed using deep learning technology at Fujifilm’s Tokyo-based global AI technology center, CAD EYE has been validated in multiple studies using histologically confirmed polyps in clinical images obtained through Fujifilm’s state-of-the-art endoscopy systems.
The technology is specifically engineered to enhance the detection of lesions that may be challenging to identify, including flat lesions, those at the periphery of the endoscopic view, and multiple lesions within a single frame. When CAD EYE detects a suspicious polyp, it triggers visual and auditory alerts for the physician, including a “Detection Box” overlay, a “Visual Assist Circle” illumination, and an audible alert, customizable according to user preferences.
Colorectal cancer remains a significant public health concern, and colonoscopy is a primary method for its prevention and early intervention. Tai Fujita, General Manager of Endoscopy at FUJIFILM Healthcare Americas Corporation, emphasizes the potential of CAD EYE to enhance the quality of colonoscopy procedures and improve patient outcomes.
Studies have demonstrated the effectiveness of CAD EYE in colorectal cancer detection and diagnosis. It detects significantly more adenomas during screening and surveillance compared to conventional high-definition colonoscopy without AI assistance, without increasing procedure time. Additionally, it exhibits a 17% higher adenoma per colonoscopy (APC) rate compared to high-definition conventional colonoscopy.
Gastroenterologists, such as Dr. Sravanthi Parasa MD FASGE from Swedish Medical Center, recognize the significance of Fujifilm’s AI CAD polyp detection algorithm in early lesion detection and reducing the risk of missed lesions. The FDA approval of CAD EYE marks a pivotal advancement in gastrointestinal healthcare, empowering healthcare providers to safeguard patient health with precision and technological innovation.
CAD EYE can be seamlessly integrated with both White Light Imaging and Linked Color Imaging (LCI), Fujifilm’s enhanced visualization mode. LCI differentiates the red color spectrum to enhance mucosal visualization, improving the detection and documentation of colonic polyps. Both CAD EYE and LCI can be easily activated at the touch of a button, streamlining the endoscopic imaging process.
