Artificial intelligence solution that can detect lesions during colonoscopies cleared by FDA

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags AI Artificial intelligence Research machine learning Patient centricity Cancer Clinical trials

The US Food and Drug Administration (FDA) has today (July 31) given clearance via its 510(k) process to one of the artificial intelligence solutions cleared for colonoscopy.

Israeli-based technology company, Magentiq-Eye, was formed in 2014 and announced the clearance of Magentiq-Colo, an AI gastrointestinal lesion software detection system that helps detect lesions in real time during colonoscopy procedures.

The company says its device will offer the gastroenterology community and its patients a significant increase in Adenoma Detection Rate (ADR) and will be available in the US in the coming weeks.

The FDA clearance comes on the heels of the European CE Mark and Israel AMAR approval, which were received in mid-2021, opening doors to one of the most significant markets for this category of medical devices.

“FDA clearance is a major milestone, and we are very proud to join only a handful of companies in the field of AI-aided colonoscopy to be granted clearance. Our next step will be to pursue opportunities in the U.S. market as we look forward to increasing the accuracy of detecting early signs of CRC and taking part in saving the lives of thousands of Americans,” says Dror Zur, founder and CEO of Magentiq-Eye.

“Although the sense of accomplishment is strong, I believe this is only the tip of the iceberg for AI in gastroenterology, so stay tuned for new products and features from us coming soon.”

Third leading cause of cancer death

In its research, the company found that according to the National Institutes of Health (NIH), colorectal cancer (CRC) ranks as the third-leading cause of cancer-related death in the United States. CRC usually originates from mucosal abnormalities such as polyps or other precancerous growths in the colon or rectum, which can be detected during colonoscopy, a screening and surveillance process that involves inserting an endoscope equipped with a camera at its tip through the rectum and navigating along the entire length of the colon in search of abnormalities.

Magentiq-Eye said that although colonoscopy has become the standard of care in most developed countries, with 15 million to 20 million procedures performed annually in the United States alone, high missed rates and undetected adenomas during colonoscopy procedures mean that even patients who are being regularly screened are still at risk of developing colon cancer.

It says 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.

In a comprehensive study performed in 2022 across 10 leading medical centers with 29 endoscopy experts and more than 950 enrolled patients, Magentiq-Colo was validated as one of the best performing artificial intelligence (AI) solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which is translated into a 21% decrease in CRC occurrence and a 35% decrease in patient mortality.

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