FDA Approves AI Algorithm for Wrist Fracture Detection

In a continued focus on improving digital health technology, the United States Food and Drug Administration has permitted marketing of an artificial intelligence (AI)-based algorithm for detection of wrist fractures. The software, known as OsteoDetect, effectively identifies distal radius fractures in two-dimensional X-ray images. The device is intended as an adjunct and not a replacement for clinician review of radiographs, the FDA noted. In retrospective studies submitted to the FDA for the approval, use of the device increased sensitivity and specificity as well as both positive and negative predictive values when compared with standard methods. "Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions," said Robert Ochs, PhD, the acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, in a statement.