Cosmo Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its GI Genius intelligent endoscopy system for lesion detection during colonoscopy.

The device uses artificial intelligence (AI) based on machine learning to help clinicians identify lesions such as polyps or suspected tumours in the colon in real-time during a colonoscopy.

The GI Genius features hardware and software that highlight portions of the colon where it identifies a potential lesion. The AI algorithm techniques will be used by the software for the identification of regions of interest.

Cosmo CEO Alessandro Della Chà said: “This approval is gratifying in many ways as it is aligned with our mission of serving markets with unmet needs.

“Through our global distribution partnership with Medtronic we are excited to pursue an opportunity which is worth at least $ 1.1bn, looking only at the opportunity for artificial intelligence in the colonoscopy market.

“Leveraging on the strength of Medtronic’s large US commercial footprint, we look forward to successfully and rapidly developing this market.”

The system produces markers during a colonoscopy and superimposes them on the video from the endoscope camera upon the detection of a potential lesion. The markers generated look like green squares and are accompanied by a short, low-volume sound.

The signs may point out the need for further assessment by the clinician such as a closer visual inspection, tissue sampling, testing or removal, or ablation of (burning) the lesion.

In addition, the GI Genius is said to be compatible with multiple FDA-cleared standard video endoscopy systems.

The FDA evaluated the safety and effectiveness of the GI Genius via a multicentre, prospective, randomised and controlled study in Italy with 700 subjects.

The subjects are between 40 years and 80 years old who were undergoing a colonoscopy for colorectal cancer screening, surveillance, positive results from a previous fecal immunochemical test for blood in the stool or gastrointestinal symptoms of possible colorectal cancer.

In the study, the colonoscopy plus GI Genius was able to detect lab-confirmed adenomas or carcinomas in 55.1% of patients compared to detecting them in 42% of patients with standard colonoscopy.