Device Using AI to Detect Colon Cancer Wins FDA Authorization
Colorectal cancer is the third leading cause of death from cancer in the United States, according to the National Institutes of Health. A device recently authorized by FDA intends to enable earlier detection of this cancer by finding lesions in the colon in real time: The GI Genius, developed by Cosmo Artificial Intelligence, Ltd., is the first device that uses artificial intelligence based on machine learning for this purpose.
“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, Ph.D. acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in CDRH. “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 software in the GI Genius uses an artificial intelligence algorithm to find areas of interest and signal potential lesions. From there the clinician can determine whether additional inspection, sampling, testing, removal or ablation of the lesion is necessary.
The device was reviewed via the De novo premarket review pathway and is compatible with many FDA-cleared standard video endoscope systems, according to the agency.
Related Articles
-
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
-
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance,…
-
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory…
-
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
