AI-enabled Tool for Colonoscopies Receives FDA Clearance

An AI-powered gastrointestinal tool that detects a "significant" increase in lesions during colonoscopies was cleared by the FDA, according to its Israeli maker.

Magentiq-Eye developed a device called Magentiq-Colo that works in real-time during colonoscopy procedures to find adenomas, or lesions. The technology has already received Israel AMAR and European CE Mark approval in mid-2021, the company said.

A colonoscopy is a screening process in which an endoscope with a camera is inserted through the rectum to navigate the entire length of the colon to look for abnormalities.

Colorectal cancer often begins with abnormalities, such as polyps or other precancerous growths in the colon or rectum. It is the third-leading cause of cancer-related deaths in the United States, according to the National Institutes of Health. Each year, there are 15 million to 20 million colonoscopies performed, and there are still errors in the detection of adenomas. An estimated 8% to 10% of colorectal cancers begin with a missed polyp that can potentially lead to interval cancer.

The device was validated in a comprehensive study with over 950 enrolled patients and 29 endoscopy experts in 2022, according to the company. The adenoma detection rate (ADR) increased by 26% relatively (7% in absolute value). The positive outcome resulted in a 35% decrease in patient mortality and a 21% decrease in colorectal cancer occurrence.  

The device received FDA 510(k) clearance, which means the device is "as safe and effective, that is, substantially equivalent, to a legally marketed device," according to the FDA.

"FDA clearance is a major milestone," said Dror Zur, CEO of Magentiq-Eye, a company he founded in 2014. "Our next step will be to pursue opportunities in the U.S. market."

Magentiq-Colo will be distributed through a local U.S. subsidiary and agent network that is being established.