'GI Genius'

FDA authorizes marketing of first AI device to help colon cancer early detection

The U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.

“Artificial intelligence has the potential to transform health care to better assist health care providers and improve patient care. When AI is combined with traditional screenings or surveillance methods, it could help find problems early on, when they may be easier to treat,” 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. “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.” 

According to the National Institutes of Health, colorectal cancer is the third leading cause of death from cancer in the United States. Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). More details on the FDA website.

11.04.2021

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