The Food and Drug Administration has granted De Novo authorization to GI Genius, the first-of-its-kind device that uses artificial intelligence to help clinicians identify polyps in real time during colonoscopies.

Manufactured by Cosmo Pharmaceuticals and distributed by Medtronic, the GI Genius software and hardware can be applied to most colonoscopy videos to assist in the detection of precancerous lesions.

During a colonoscopy, the AI-enabled system places green squares around potential lesions and alerts clinicians with a low-volume sound signaling that further examination may be needed.

The system is not intended to diagnose or instruct clinicians on how to manage suspicious polyps, according to the FDA.

“It is up to the clinician to decide whether the identified region actually contains a suspected lesion, and how the lesion should be managed and processed per standard clinical practice and guidelines,” the agency said in its announcement.

In addition to the United States, the GI Genius module is available in Europe and select markets in Asia, Australia and the Middle East.

WHAT’S THE IMPACT?

Despite being highly preventable through regular screenings, colorectal cancer is the third most common cancer among men and women and is the third leading cause of cancer-related deaths in the U.S., according to the Centers for Disease Control and Prevention.

Even with regular screenings, sometimes clinicians miss lesions. In fact, studies show that about a quarter of adenomas are missed during colonoscopies.

The GI Genius module is designed to act as a second observer during colonoscopies to help make sure potentially dangerous lesions aren’t overlooked.

In its clinical trial, the device identified lab-confirmed polyps in 55.1% of patients, compared to the 42% of patients who were identified with standard colonoscopy.

THE LARGER TREND

No stranger to the gastrointestinal space, Medtronic’s Pillcam Colon 2 technology is currently being tested in England. The miniature camera takes images as it passes through the bowel, and these are transmitted to a recording device worn by the patient at their waist. After the camera has passed through the body it can be flushed away.

Others working in the colon cancer prevention space include Medial EarlySign, which developed an AI system that scans electronic health records looking for at-risk patients. In a 2018 study, it flagged about 8% of patients in a large trial group, who were later diagnosed with cancer or precancerous lesions.

ON THE RECORD

"Medtronic is committed to preventing colorectal cancer and improving patient outcomes with disruptive technologies that aid screening, increase patient compliance, and improve treatment," Giovanni Di Napoli, president of Medtronic’s gastrointestinal business, said in a statement.

"With FDA de novo clearance for the GI Genius and its AI capabilities, we expect to enhance and improve colonoscopies and polyp detection. By introducing AI technology into the colonoscopy market, we anticipate improving colonoscopy detection rates and reducing variability in patient outcomes."