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16th April 2021

FDA greenlights first AI colon cancer detection device

The U.S. Food and Drug Administration (FDA) approve the GI Genius, the first device to employ AI in bid to detect early signs of colon cancer

On April 9, 2021, the U.S. Food and Drug Administration announced via a press release the authorisation of the GI Genius, the first device that uses artificial intelligence (AI) to help detect potential signs of colon cancer.
The GI Genius works by assisting clinicians in detecting polyps or suspected tumours in the colon during a colonoscopy. The device is not intended for diagnostic assessments or suspicious polyps management, it is thus up to the clinician to decide the prognosis an lesion management.
According to the National Institutes of Health, colorectal cancer is the third leading cause of death from cancer in the United States.
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 shared:

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,
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.

The FDA Center for Devices and Radiological Health’s Digital Health Center of Excellence is pioneering the search for AI-based technology to shape the future.
See also: FDA-approved Memic close a $96M Series D funding round for its robot-assisted surgery platform for use in transvaginal benign surgical procedures
Source: The U.S. FDA