FDA Authorizes Marketing of First AI Device to Detect Signs of Colon Cancer

Courtney H. Lias, PhD

The FDA has authorized the marketing of the first device that utilizes artificial intelligence (AI) based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.¹

The device, dubbed the GI Genius, is comprised of hardware and software that was developed to highlight portions of the colon where the device identifies a possible lesion. By using AI algorithm techniques, the device is able to reveal regions of interest.

During the colonoscopy, the system produces markers that look like green squares and are accompanied by a short, low-volume sound. These markers are superimposed on the video from the endoscope camera when a possible lesion is identified. When this happens, it signifies that a further assessment may be needed, whether that be closer visual inspection, tissue sampling, testing or removal, or ablation of the lesion.

“AI has the potential to transform healthcare to better assist healthcare providers and improve patient care. When AI is combined with traditional screenings or surveillance methods, it could help find problems early on, when they may be easier to treat,” Courtney H. Lias, PhD, acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in the FDA’s Center for Devices and Radiological Health, stated in a press release.

Colorectal cancer (CRC) is the third leading cause of death from cancer in the United States, according to the National Institutes of Health. Colonoscopies are performed to identify any changes or abnormalities in the lining of the colon and rectum. The GI Genius was developed to have compatibility with several FDA-authorized standard video endoscopy systems.

The safety and effectiveness of the GI Genius was examined through a multicenter, prospective, controlled study done in Italy, which enrolled a total of 700 patients who were aged between 70 years and 80 years who were undergoing a colonoscopy for CRC screening, surveillance, and who had positive results from a prior fecal immunochemical test for blood in the stool or gastrointestinal symptoms of possible CRC.

The primary analyses that were done had been based on a subgroup of 263 patients who underwent screening or surveillance every 3 years or more. Patients were randomized to receive either white light standard colonoscopy with the GI Genius (n = 136) or white light colonoscopy alone (n = 127). The primary end point of the trial was to compare how often colonoscopy plus GI Genius was able to identify a patient with at least 1 lab-confirmed adenoma or carcinoma vs standard colonoscopy alone.

Results indicated that the system identified laboratory-confirmed adenomas or carcinomas in 55.1% of patients vs 42.0% identified with standard colonoscopy; this translated to an observed difference of 13%. The device resulted in more biopsies conducted, but no perforations, infections, or bleeding was observed with the additional tests. However, investigators noted a slight increase in the number of lesions biopsied that did not turn out to be adenomas.

Importantly, the system is not supposed to characterize or classify a lesion, and it should not replace laboratory sampling as a means of diagnosis. “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 a statement issued by the FDA.

The system identifies areas of the colon within the field of view of the endoscope where a colorectal polyp could potentially be and allows for more extended examination in real time during the colonoscopy. The clinician must determine whether the region identified actually does have a suspected lesion and how that lesion should be managed and processed per standard guidelines.

The GI Genius was reviewed through the De Novo premarket review pathway.

“Medtronic is committed to preventing CRC and improving patient outcomes with disruptive technologies that aid screening, increase patient compliance, and improve treatment,” Giovanni DiNapoli, president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic, stated in a press release.² “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.”

References

1. FDA authorizes marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer. News release. FDA. April 9, 2021. Accessed April 12, 2021. https://bit.ly/3tb0DZW
2. US FDA grants de novo clearance for first and only artificial intelligence system for colonoscopy; Medtronic launches GI Genius intelligent endoscopy module. News release. Medtronic plc. April 12, 2021. Accessed April 12, 2021. https://bit.ly/3dVlJVP