The U.S. Food and Drug Administration has approved the marketing of an artificial intelligence algorithm that helps detect wrist fractures.
On Thursday, May 24, the FDA approved an AI-based software to detect wrist fractures. The software called OsteoDetect uses artificial intelligence to help doctors make a diagnosis faster.
FDA Approves AI-Based Software For Wrist Fracture Detection
On Thursday, May 24, the agency announced the approval of an AI-powered diagnosis and detection software called OsteoDetect, which allows doctors to speed up the process of identifying wrist fractures in adults.
The software, developed by New York-based company Imagen technologies, uses artificial intelligence to analyze two-dimensional wrist x-rays and spot fractures in the distal radius, which is known as one of the most commonly broken bones in the arm. The software then demarcates the area on the image for further review by a doctor.
“Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions,” said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
FDA Granted Approval After Reviewing Study Results
The FDA approved the diagnostic tool after reviewing results of a retrospective study submitted by the company. The agency found that the study, which included as many as 1,000 radiograph images, substantiated the algorithm’s ability to diagnose wrist fractures as accurately as human doctors.
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