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.

The Food and Drug Administration has cleared new computer-aided detection and diagnosis software that uses an artificial intelligence algorithm to analyze X-ray images to detect wrist fractures in adult patients. The OsteoDetect software from Imagen Technologies, which was reviewed through the De Novo premarket regulatory pathway for low to moderate risk devices, analyzes wrist radiographs using machine learning techniques to identify and highlight regions of distal radius fracture--a common type of wrist fracture--to aid detection and diagnosis. "Artificial intelligence algorithms have tremendous potential to help healthcare providers diagnose and treat medical conditions," said Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures." According to the FDA, the software is "intended to be used by clinicians in various settings, including primary care, emergency medicine, urgent care and specialty care, such as orthopedics."