The U.S. Food and Drug Administration has approved the marketing of an artificial intelligence algorithm that helps detect wrist fractures.
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.
The agency also reviewed results of a separate study that documented the performance of 24 providers who used the AI-based software. It concluded that OsteoDetect gives better results when it comes to "sensitivity, specificity, and positive and negative predictive values."
FDA To Speed Up Approvals For AI-Based Devices And Tools
It might be a while before doctors start using OsteoDetect as a diagnostic tool. However, one might considerably see a more frequent use of artificial intelligence in the field of medicine onward.
Last month, Scott Gottlieb, the FDA commissioner, said that the agency is working with experts to lay down new rules and regulations that would enable regulators to keep up with technologies like AI and encourage innovation in the field.
Other FDA-Approved AI Devices
The OsteoDetect isn't the first AI-based tool that has been approved by the FDA this year. Last month, the agency approved a medical device that uses artificial intelligence to help diagnose a condition known as retinopathy, which is common in diabetes patients and could lead to vision impairment.
Earlier this year, the FDA greenlit another AI-based clinical decision support software that analyzes CT scans and helps detect strokes.