The U.S. 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 the signs of wrist fractures.
“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.
“This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures.” OsteoDetect isn’t about to replace doctors but it can help improve fracture detection and get the correct diagnosis and treatment quickly.
The software marks where it suspects the fracture to be, helping doctors make the final diagnosis decisions. To get approval Imagen submitted a retrospective study of 1,000 radiograph images that assessed the independent performance of the software against the performance of three board certified orthopedic hand surgeons.
The study found that doctors were able to more specifically diagnose a wrist fracture in terms of location and type when raised by OsteoDetect While an approval of a new tool like this doesn’t mean it will get into doctors offices and emergency rooms immediately it is another sign that AI-diagnostic tools are becoming more common.
Scott Gottlieb, FDA commissioner recently said his organization was working with experts to make sure they stayed up to date with emerging technologies like AI. OsteoDetect was approved quickly through the De Novo premarket review pathway, which streamlines the process for products with "low to moderate risk."
The FDA has approved a raft of AI-diagnostic tools this year including an AI algorithm that can detect a ‘greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.’ Diabetic retinopathy is caused when sustained high levels of blood sugar damage the blood vessels of the retina, the light-sensitive tissue in the back of the eye.
It is the most common cause of sight-loss among diabetics and is the leading cause of blindness in working age adults in North America. Commenting on the approval Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health said, “Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis."
Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care.