Fujifilm Healthcare Americas has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new AI-based endoscopic imaging detection system, CAD EYE.
CAD EYE works in real-time and is designed to improve the detection of colonic lesions such as adenomas and polyps at the time of colonoscopy procedures. It aids endoscopists in identifying and removing pre-cancerous lesions of varying sizes, shapes, and colours.
The system comprises the Fujifilm EX-1 expansion unit and the EW10-EC02 endoscopy support software and is an advancement of the existing ELUXEO Endoscopic Imaging System.
CAD EYE's AI image processing is tailored for seamless integration with the system's processor and the endoscope, enhancing imaging capabilities.
It utilises deep learning technology and has been validated through multiple studies involving histologically confirmed polyps captured by Fujifilm endoscopy systems.
The technology is claimed to be adept at spotting lesions that are traditionally challenging to detect. For example, flat lesions which are hidden in the endoscopic view's corners, and instances where multiple lesions appear simultaneously.
Upon detecting a suspicious polyp, CAD EYE provides physicians with visual and auditory alerts, including a Detection Box, a Visual Assist Circle, and an alert sound.
These alerts are designed to complement rather than disrupt the physician's existing workflow by overlaying visual cues on the clinical images.
Fujifilm Healthcare Americas endoscopy general manager Tai Fujita said: “Colorectal cancer is the second leading cause of cancer deaths in US women and men combined, despite screening – primarily colonoscopy – being one of the most reliable and effective methods for cancer prevention and early intervention.
“Every day we pride ourselves on delivering what we believe is the highest quality imaging and optics, arming endoscopists with the tools they need to combat this public health issue. Today, we’re thrilled to take that a step further with the introduction of CAD EYE, which has the potential to dramatically improve the quality of colonoscopy.”
Clinical studies have demonstrated that CAD EYE can enhance colorectal cancer detection and diagnosis.
It has been shown to identify more adenomas during screenings and surveillance than high-definition colonoscopy without AI and achieves a 17% higher adenoma per colonoscopy (APC) rate.
Furthermore, CAD EYE's detection capabilities are comparable to those of an expert and exceed those of a novice. The commercial availability of the system is anticipated for early 2024, following a limited market evaluation.
