FDA Approves Marketing of AI Medical Device to Detect Colon Cancer

April 14, 2021 - FDA recently authorized marketing of the GI Genius, a medical device that uses artificial intelligence (AI) to assist clinicians in detecting signs of colon cancer. 

GI Genius is based on machine learning and uses an AI algorithm to highlight portions of the colon where there may be a potential lesion, including polyps or suspected tumors, in real time during a colonoscopy. 

The device generates markers accompanied by a short, low-volume sound and displays them on the video from the endoscope camera when it identifies a potential lesion.

The software then signals to the clinician that further assessment may be needed, including visual inspection, tissue sampling, testing or removal, or ablation of the lesion. 

“Artificial intelligence has the potential to transform health care to better assist health care 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, said in the announcement.

“Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians. Clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise,” Lias continued. 

FDA based its authorization on a multicenter, controlled study of 700 participants between the ages of 40 to 80 years who were undergoing a colonoscopy for colon cancer screening, surveillance, or because of positive results from previous fecal immunochemical test for blood in the stool.

The primary analyses from the study were based on a sub-population of 263 patients who were being screened or surveilled every three years or more. 

The primary endpoint of the study was how often colonoscopy plus GI Genius identified a patient with at least one lab-confirmed precancerous tumor (adenoma), or cancerous tumor (carcinoma), to standard of care. 

Researchers found that colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1 percent of patients compared to 42 percent of patients with standard colonoscopy, FDA stated.

Colon cancer is the third leading cause of cancer-related deaths in the US and generally starts from polyps or other precancerous growths in the rectum or the colon. Clinicians perform colonoscopies to detect changes or abnormalities in the lining of the colon or rectum. 

The GI Genius is designed to be compatible with numerous FDA-cleared standard video endoscopy systems.

The agency stated that although this device led to more biopsies being performed, there were no adverse events reported with the additional biopsies, such as perforations, infections, or bleeding.

Additionally, there was a slight uptick in the number of lesions biopsied that were not adenomas. 

FDA emphasized that GI Genius is not intended to classify a lesion or replace lab sampling as a means of diagnosis. The device also does not provide any diagnostic assessments of colorectal polyps.

GI Genius strictly identifies regions of the colon within the endoscope’s field of view where a polyp could be located. It is then up to the clinician to decide the appropriate next steps. 

FDA’s approval of the device, developed by Cosmo Pharmaceuticals, marks a milestone for the company after over 10 years of research to generate innovations for colon cancer and colonoscopy procedures. 

"This landmark approval is tremendous news for Cosmo. The first ever approval of an artificial intelligence device for lesion detection in colonoscopies further strengthens Cosmo's commitment to fight colorectal cancer,” Mauro Ajani, chairman of Cosmo Artificial Intelligence, said in a press release following the approval. 

“This approval is a major milestone after many years of strategic investments into the colon diseases and positions Cosmo at the forefront of cutting-edge innovation,” Ajani continued.