FUJIFILM Healthcare Americas Corporation has received 510(k) clearance from the FDA for CAD EYE, a novel AI detection system for endoscopic imaging. CAD EYE is designed to enable real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures. It supports endoscopists in detecting and removing pre-cancerous lesions, regardless of size, shape, and color. This advanced technology can detect lesions that may be difficult to identify, such as flat lesions, those in the corner of the endoscopic view, and multiple lesions in a single frame. When a suspicious polyp is detected, CAD EYE provides visual and auditory alerts to the physician, ensuring that potential abnormalities are not missed.

Studies have shown that CAD EYE can lead to significant advances in colorectal cancer detection and diagnosis. It has been found to detect significantly more adenomas during screening and surveillance compared to conventional high-definition colonoscopy without AI assistance. CAD EYE also detects colorectal neoplastic lesions at a level comparable to that of an expert and superior to that of a beginner. These findings highlight the potential of CAD EYE to improve the quality of colonoscopy procedures and enhance patient outcomes.

CAD EYE can be used 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 launched at the touch of a button, providing endoscopists with seamless integration into their existing workflow.

CAD EYE will be commercially available in spring 2024, following the completion of a limited market evaluation. This innovative AI detection system has the potential to revolutionize colorectal cancer detection and prevention, helping to reduce the incidence and mortality rates associated with this disease. By providing real-time detection and alerts during colonoscopy procedures, CAD EYE empowers endoscopists to identify and remove pre-cancerous lesions, ultimately improving patient outcomes.