The Food and Drug Administration last year approved its first autonomous, artificially intelligent medical device.
In a decision that seemed to take a page from science fiction, the FDA gave the OK to the IDx-DR, a device that uses artificial intelligence to analyze images of the back of a patient’s eye to detect if they have diabetic retinopathy.
It’s the first FDA-approved device to provide a screening decision without requiring a clinician to interpret the results—which means providers who aren’t eye specialists, such as primary-care physicians, can rely on it to screen for the eye disease.
“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary-care doctor’s office,” Dr. Malvina Eydelman, director of the division of ophthalmic and ear, nose and throat devices at the FDA’s Center for Devices and Radiological Health, said at the time. “The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed healthcare,” she added.
IDx sells the system in a bundle that costs around $20,000, which includes hardware installation, training and the retinal camera; the company does not manufacture the camera.
But in part because of the way the device was approved—using a fast-track approach established by the 21st Century Cures Act—the device was met with some skepticism. In the wake of the approval, researchers—mainly those involved with other healthcare AI projects at competing vendors—questioned aspects of the clinical study the FDA reviewed to evaluate IDx-DR, criticizing its sample size of patients from 10 primary-care sites, and whether longer-term studies would in fact illustrate a clinical benefit to patients.
IDx-DR moved through the FDA’s approval process in 85 days under the agency’s de novo pre-market review pathway, although the company said it was in conversations with the FDA for eight years prior to submitting an application. The device was part of the agency’s Breakthrough Device Program, which was established as part of the Cures Act—a landmark piece of legislation signed into law during the final month of the Obama administration.
At more than 300 pages, it contained a number of moving parts—funds for the National Institutes of Health, a new HHS assistant secretary for mental health and substance use, and an interoperability framework, not to mention dozens of measures meant to streamline a supposedly outdated regulatory process at the FDA.
“It has enabled the FDA to think more broadly and more strategically about how it can adapt to a very rapidly changing world in terms of the drug developments, the device developments, the digital health developments that are happening,” said Hannah Bornstein, deputy practice group leader for government investigations and white collar defense at the law firm Nixon Peabody.