The FDA approved an artificial intelligence (AI) device to help clinicians identify potential signs of colon cancer during a colonoscopy.
The GI Genius uses an AI algorithm to detect potential lesions, such as polyps or suspected tumors, and generates markers that are then superimposed over the video from the endoscope camera to assist clinicians in identifying areas that warrant further examination, including closer visual inspection, tissue sampling, testing or removal, or ablation of the lesion, the FDA explained — and, the agency added, the device is designed to be compatible with many currently approved video endoscopy systems.
“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,” said 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, in a statement. “Studies show that during colorectal cancer screenings, missed lesions can be a problem even for well-trained clinicians. With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise.”
The FDA emphasized that, while the GI Genius can potentially assist in finding colon cancer lesions, the device is “not intended to characterize or classify a lesion, nor to replace lab 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. 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.”
This approval was based on results from a multicenter, prospective, randomized, controlled study from Italy that was conducted among 700 patients ages 40-80 years who were undergoing colonoscopy for colorectal cancer screening, surveillance, positive results from a previous fecal occult blood test, or gastrointestinal symptoms of possible colorectal cancer.
Results of the primary analyses were based on a sub-population of 263 patients who were being screened or surveilled every three years or more, the agency explained. Of these, 136 patients underwent white light standard colonoscopy with the GI Genius, while 127 underwent white light standard colonoscopy alone.
“The primary endpoint of the study compared how often colonoscopy plus GI Genius identified a patient with at least one lab-confirmed adenoma or carcinoma to how often standard colonoscopy made the same identifications,” the FDA wrote. “In the study, colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1% of patients compared to identifying them in 42.0% of patients with standard colonoscopy, an observed difference of 13%.”
The FDA noted that, while use of the device led to more biopsies being performed, there were no adverse events reported with the additional biopsies — but there was a slight increase in biopsies of lesions that were not adenomas, the agency added.
The GI Genius is manufactured by Cosmo Artificial Intelligence, Ltd.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 23
Topic ID: 78,23,730,16,23,192,725,925
