FDA Authorizes Marketing of First Device that Uses Artificia

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer


FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance
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SILVER SPRING, Md., April 9, 2021 /PRNewswire/ -- Today, 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. "

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