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# Imagen De Novo OK for AI Software Fracture Finder
- URL: https://www.fdaweb.com/imagen-de-novo-ok-for-ai-software-fracture-finder/
- Published: 2018-05-25T12:00:00.000Z
- Updated: 2026-09-15T00:08:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141537

FDA has granted Imagen a *de novo* marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to locate wrist fractures in adult patients. The software uses an artificial intelligence algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture, a common type of wrist fracture, an FDA [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608833.htm?ref=fdaweb.com) says. It marks the location of the fracture on the image to aid in detection and diagnosis.

To gain marketing authorization, FDA says 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,” the agency says.