FDA Clears AI-Assisted Colonoscopy Device
The US Food and Drug Administration (FDA) today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.
The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.
In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.
In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology (UEG) Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6-9 mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”
The device “takes the video out of the colonoscopy device, breaks it into frames, analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained to Medscape Medical News. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”
As previously reported by Medscape Medical News, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.
Colonoscopy has become standard in most developed countries, with 15 million to 20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.
“A missed polyp can lead to interval cancer, which accounts for approximately 8% to 10% of all CRC in the US, translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.
According to the National Institutes of Health, colorectal cancer (CRC) is the third-leading cause of cancer-related death in the United States.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @MLfrellick.
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