Intelligence-based medical imaging diagnostic group Imagen Technologies today won FDA de novo clearance for its OsteoDetect computer-aided diagnosis software designed to detect wrist fractures in adult patients.
The New York-based company’s OsteoDetect software is designed to analyze wrist radiographs using machine learning algorithms to identify regions of distal radius fracturing during the review of posterior-anterior and medial-lateral X-ray images of adult wrists, according to an FDA release.
Approval came based off a retrospective study of 1,000 radiograph imagines assessing independent performance of the image analysis algorithm for detecting wrist fractures, as well as the accuracy of fracture localization in the software against the performance of three board certified orthopedic hand surgeons, the FDA said. The company also submitted a retrospective study of 200 patient cases as reviewed by 24 providers.
Both studies reportedly showed that use of the software improved the reader’s ability to detect wrist fractures and increased sensitivity, specificity and positive and negative predictive values as compared to unaided performance.
“Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions. This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures,” FDA Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health acting deputy director Robert Ochs said in an FDA release.
Last March, Imagen Technologies reportedly raised $14.3 million in a round of equity financing, according to an SEC filing.