AI-based diagnostic for wrist fractures gets FDA green light

FDA has permitted marketing of OsteoDetect, an artificial intelligence-based software product from Imagen Technologies (New York, N.Y.), as an adjunct tool to detect and diagnose wrist fracture in adults. The clearance came via FDA's de novo premarket review pathway.

OsteoDetect analyzes posterior-anterior and medial-lateral X-ray images for signs of distal radius fracture, using machine learning to identify and highlight fracture regions. FDA said data from a pair of retrospective trials showed using OsteoDetect improved readers' performance at detecting wrist fractures compared with their unaided performance...