FDA approves AI software to detect wrist fractures

Matt O'Connor | | Health Imaging | Policy & Regulations

The Food and Drug Administration (FDA) gave software company Imagen permission to market its artificial intelligence (AI) diagnostic system OsteoDetect.

The system is designed to detect wrist fractures in adult patients by reading wrist radiographs, according to an FDA statement. However, the group cautioned that the machine learning technique is not meant to replace a human clinician’s review of images.

“Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions,” said Robert Ochs, PhD, and acting deputy director for 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.”

To receive FDA clearance, the company submitted a retrospective study of 1,000 radiograph images that were analyzed by both the AI algorithm and three board-certified orthopedic hand surgeons. Imagen also included a retrospective study of 24 providers who reviewed 200 patient cases. Each study found the readers’ ability to detect wrist fractures was improved when using the software.

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Matt O'Connor

Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.

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