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FDA approves AI tool that can detect wrist fractures



The US Food and Drug Administration (FDA) has just approved an AI-based diagnostic tool that can accurately detect wrist fractures. Imagene's OsteoDetect uses machine learning algorithms to study 2D X-rays for signs of wrist fractures.

"Artificial intelligence algorithms have tremendous potential to help healthcare providers diagnose and treat disease," said Robert Ochs, Ph.D. Deputy Director of Radiological Health, Office of In Vitro Diagnostics and Radiological Health at the FDA for Equipment and Radiological Health.

"This software can help vendors to more quickly detect wrist fractures and help diagnose fractures." OsteoDetect does not replace doctors, but can help improve fracture detection and get the right diagnosis and treatment quickly.

The software marks the site where the fracture is suspected and helps physicians make the final diagnostic decisions. To obtain approval, Imagen completed a retrospective study of 1

,000 X-ray images assessing the independent performance of the software against the performance of three certified orthopedic hand surgeons.

The study found that OsteoDetect doctors were able to diagnose osteoporosis for OsteoDetect diagnosis and OsteoDetect diagnosis. However, approval of a new instrument like this does not mean that it will go straight to doctors' offices and emergency rooms. It's another sign that AI diagnostic tools are becoming more common.

Scott Gottlieb, FDA Commissioner, said recently that his organization works with experts to ensure that they keep up with new technologies such as AI. OsteoDetect was quickly approved by the De Novo pre-market review route, which streamlines the process for low-to-medium risk products.

The FDA has approved a number of AI diagnostic tools this year, including an AI algorithm that allows diabetics to detect "diabetic retinopathy that is greater than the mildness of eye disease." Diabetic retinopathy is caused when persistently high Blood sugar levels damage the blood vessels of the retina, the photosensitive tissue in the fundus.

It is the leading cause of vision loss in diabetics and is the leading cause of blindness in working-age adults in North America. Commenting on approval Malvina Eydelman, MD, director of the Department of Ophthalmology and Otolaryngology at the FDA Center for Equipment and Radiological Health said, "Early detection of retinopathy is an important part of caring for millions of people with diabetes However, many patients with diabetes are not adequately screened for diabetic retinopathy, as about 50 percent of them do not see their ophthalmologist every year. "

Today's Decision Allows the Commercialization of a Novel Artificial Intelligence Technology The FDA will continue to monitor the availability of enable safe and effective digital health devices that can improve patients' access to the health care they need.


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