The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes.
IDx’s software uses an algorithm to analyze images of the eye taken with a retinal camera. A doctor uploads the images to a cloud server with IDx-DR software, which then tells the physician if it detects more than mild diabetic retinopathy.
The device is the first approved by the FDA that gives a screening decision without the need for additional interpretation by the physician.
“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% of them do not see their eye doctor on a yearly basis,” Dr. Malvina Eydelman, director of the division of ophthalmic, and ear, nose and throat Devices at the FDA, said in prepared remarks.
“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,” Eydelman added.
To evaluate how often IDx-DR could accurately identify patients with more than mild diabetic retinopathy, the FDA studied data from a clinical study of images from 900 patients with diabetes. The software could correctly detect the presence of diabetic retinopathy 87.4% of the time, the agency reported.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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