FDA Approves AI Technology For Use During Colonoscopy

The US Food and Drug Administration (FDA) has approved the marketing of GI Genius—the first device to assist clinicians using artificial intelligence (AI) and machine learning in detecting lesions during a colonoscopy, in real-time. The AI device will assist with diagnosing lesions in the colon, such as suspected tumors or polyps, and aid clinicians in early and accurate diagnosis.

The GI Genius was designed to highlight areas of the colon where the device can better detect potential lesions. The AI software uses an algorithm to identify regions of interest; the GI Genius then generates “markers,” which appear as green squares and are accompanied by a short sound, which signifies a potential lesion was detected. The markers alert the clinician to take a closer look and perhaps take a tissue sample.

The device was also designed to be compatible with many standard, FDA-cleared video endoscopy systems.

“Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians. With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise,” said Courtney H. Lias, Ph.D, acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in the FDA’s Center for Devices and Radiological Health.

--Angelique Platas

Reference:

FDA authorizes marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer. News release. April 9, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-device-uses-artificial-intelligence-help-detect-potential-signs-colon