Dive Brief:

• FDA has authorized the first medical device that uses artificial intelligence to help clinicians detect in real time potential irregularities in the colon during colonoscopies.
• Medtronic is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying precancerous polyps and lesions. In addition to the U.S., the AI-assisted system is available in Europe and select markets in Asia, Australia and the Middle East. 
• The medtech giant announced in October 2019 that it partnered with Cosmo and planned to bring the system to the U.S. market, where more than 19 million colonoscopies are performed annually to identify potential signs of colorectal cancer. While the FDA assessed the safety and effectiveness of the GI Genius in a prospective, randomized study, the agency cautioned that the device is "not intended to characterize or classify a lesion, nor to replace lab sampling as a means of diagnosis."  

Dive Insight:

Colorectal cancer, the third leading cause of U.S. cancer deaths, usually starts from polyps or other precancerous growths in the rectum or the colon. Colonoscopies enable gastroenterologists to identify polyps and lesions that might potentially develop into cancer as a means of screening and surveillance. 

However, studies have shown that during colorectal cancer screenings "missed lesions can be a problem even for well-trained clinicians," according to Courtney Lias, acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office at the FDA Center for Devices and Radiological Health.

Lias contends that as a result of the FDA's authorization of the GI Genius, which is designed to highlight portions of the colon where the device detects a potential lesion, clinicians "now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise."

FDA evaluated the safety and effectiveness of the AI-assisted system in an Italian multicenter study of 700 subjects in which the primary endpoint compared how often colonoscopy plus GI Genius identified a patient with at least one lab-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor) to how often standard colonoscopy made the same identifications.

The study's results showed that colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1% of patients compared to 42% of patients with standard colonoscopy.

Giovanni Di Napoli, president of Medtronic's gastrointestinal business, said in a statement that with FDA's De Novo clearance of GI Genius the medtech giant anticipates "improving colonoscopy detection rates and reducing variability in patient outcomes."

Nonetheless, while the AI software uses algorithms to identify regions of interest during a colonoscopy and marks abnormalities consistent with polyps, the device does not provide any diagnostic assessments of colorectal polyp pathology, nor does it suggest to the clinician how to manage suspicious polyps, according to FDA. 

"GI Genius only identifies regions of the colon within the endoscope's field of view where a colorectal polyp might be located, allowing for a more extended examination in real-time during colonoscopy. 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. 

Medtronic claims GI Genius is compatible with any colonoscope video, while FDA's announcement states that the AI-based system is designed to be compatible with many FDA-cleared standard video endoscopy systems.