The U.S. Food & Drug Administration has granted de novo clearance for a new artificial intelligence system that helps physicians identify polyps during colorectal cancer screening.
In a Friday announcement, the FDA called GI Genius—developed by Cosmo Pharmaceuticals—the first commercially available computer-aided detection system of its kind to gain the de novo classification.
The module works with any endoscope and, in real time, visually marks potential abnormalities that may have been overlooked by physicians.
The FDA said it determined the platforms' safety and effectiveness by analyzing the results of a prospective, randomized, controlled Italian study. Findings showed gastroenterologists using the tool spotted 13% more biopsy-confirmed polyps compared to peers interpreting the same images without the AI.
Intraoperative imaging tool wins clearance
Digital surgery firm Active Surgical recently gained FDA 510(k) clearance for its novel intraoperative imaging tool, the company announced Friday.
The hardware-agnostic device enhances surgical visualization and will initially be available for perfusion exams, giving clinicians the chance to see blood flow in real time without dyes, according to the company.
CEO of the Boston-based firm Todd Unsen says the device will help improve patient outcomes and safety in the operating room.
AI-powered radiation therapy tool OK’d
In other news, the FDA awarded clearance to an artificial intelligence-powered solution that automatically contours tumors for more precise therapy treatments.
Based in Boston and Taipei, Taiwan, Vysioneer gained designation for its VBrain solution on April 5. It’s been given the OK to auto-contour three common brain tumors: brain metastasis, meningioma and acoustic neuroma.
The solution was tested at multiple sites across the U.S. and Taiwan, as well as a lengthy 18-month clinical trial, according to a statement.
Manually outlining tumors can take hours and the company believes this device can help clinicians more quickly plan radiotherapy treatment and precisely target tumors.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.