Imagen’s OsteoDetect, an AI-based diagnostic tool that can quickly detect distal radius wrist fractures. Its machine learning algorithm studies 2D X-rays for the telltale signs of fractures and marks them for closer study. It’s not a replacement for doctors or clinicians, the FDA stressed — rather, it’s to improve their detection and get the right treatment that much sooner.

OsteoDetect uses AI software to analyze two-dimensional x-ray images for distal radius fracture. The software, intended as an adjunct to clinician judgment, marks the fracture location on posterior-anterior and medial-lateral x-ray images. The company submitted a retrospective study of 1,000 radiograph images that assessed the independent performance of the image analysis algorithm for detecting wrist fractures and the accuracy of the fracture localization of OsteoDetect against the performance of three board certified orthopedic hand surgeons. Imagen also submitted a retrospective study of 24 providers who reviewed 200 patient cases. Both studies demonstrated that the readers’ performance in detecting wrist fractures was improved using the software, including increased sensitivity, specificity, positive and negative predictive values, when aided by OsteoDetect, as compared with their unaided performance according to standard clinical practice.