FDA Grants De Novo Clearance to GI Genius for Colon Cancer Identification

The US Food and Drug Administration (FDA) has granted De Novo clearance to the GI Genius device, an artificial intelligence (AI) endoscopy module to assist clinicians in colonoscopy care.

The approval, issued to Medtronic, is indicated for the identification of potential lesions including polyps or tumors during a colonoscopy.

The Device

The GI Genius uses a computer-aided detection system and AI to highlights portions of the colon where it may detect a lesion and identifies regions of interest for clinicians. Compatible with colonoscope video, the system will generate a visual marker in real-time for the clinicians and create a sound for each potential polyp or lesion, to determine if further assessment is needed.

Medtronic claims the Gi Genius model has resulted in a 14% absolute increase in adenoma detection rate (ADR) compared to colonoscopy alone for both flat and polyploid lesions.

The Study

The approval is based on the data from a randomized, controlled study in Italy, with 700 subjects from 40-80 years old. Each patient underwent a colonoscopy for colorectal cancer screening, positive results previous fecal immunochemical test or gastrointestinal symptoms of possible colorectal cancer. Study analyses were based on a subpopulation of 263 patients.

Subjects either underwent a white light standard colonoscopy with the GI Genius (n = 136) or the white light colonoscopy (n = 127) to compare identifications of patients with a lab-confirmed adenoma or carcinoma.

The study found a colonoscopy and Gi Genius together identified adenomas or carcinomas in 55.1% of patients. The standard colonoscopy alone identified adenomas or carcinomas in 42% of patients.

Safety Profile

No adverse events such as infections or bleeding were reported with the additional biopsies. A slight increase in the number of lesions biopsied that were not adenomas was observed.

"With FDA de novo clearance for the GI Genius and its AI capabilities, we expect to enhance and improve colonoscopies and polyp detection,” said Giovanni Di Napoli, president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. “By introducing AI technology into the colonoscopy market, we anticipate improving colonoscopy detection rates and reducing variability in patient outcomes."