Privately-held AI diagnostics company IDx announced earlier this month that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo request to market IDx-DR.
IDx-DR is an AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a leading cause of blindness.
More than 30 million Americans have diabetes, and an estimated 24,000 lose vision each year from diabetic retinopathy, a complication of diabetes. If diabetic retinopathy is caught in its early stages, vision loss and blindness are almost entirely preventable.
“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered,” said Dr. Michael Abràmoff, MD, Ph.D., founder and president of IDx.
“The FDA authorized our De Novo submission, and we are now cleared to sell IDx-DR,” said Ben Clark, Chief Operating Officer at IDx. “We are the first De Novo clearance from FDA under the new FDA authorization bill that was passed a couple of years ago.”
Clark explained that there are two kinds of AI in healthcare. The first kind is assisted AI, which works alongside a doctor and serves as an input in their decision-making process.
The other kind is autonomous AI, which is what IDx is working on.
As an autonomous, AI-based system, IDx-DR is unique in that it makes an assessment without the need for a clinician to also interpret the image or results, making it usable by health care providers who may not normally be involved in eye care.
For diabetics who are supposed to go to a specialist every year for a diabetic retinopathy screening, it can be a convenient way to make sure they’re getting those screenings.
IDx-DR is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA.
“It’s a major leap forward for medicine because instead of needing a specialist to oversee everything that’s happening from an algorithmic or AI perspective, you’re actually relying on AI to make a medical decision,” said Clark. “When you give AI that degree of autonomy, you can actually change the way in which healthcare is practiced.”
Clark said those changes include making healthcare and key diagnostic decisions much more available to people in a wider range of healthcare settings and lowering overall costs.
“All of a sudden you’ve made a huge leap forward in terms of increasing access to a sight-saving eye exam, you’ve got ways to detect the disease earlier, you’ve got the ability to detect on an accurate and consistent basis because the algorithms always perform at the same level,” said Clark.
IDx-DR received expedited review under the FDA’s Breakthrough Devices program following a pivotal clinical trial conducted at ten primary care sites across the U.S., which ran about 900 subjects through the IDx-DR exam.
The exam is performed on site in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with the American Academy of Ophthalmology preferred practice pattern for diabetic retinopathy.
IDx is developing additional AI-based diagnostic algorithms for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease and stroke risk.
“We’re excited to have done this in the Midwest,” said Clark. “It was great that we were able to do this as a small company spun out of the University of Iowa that’s really had our nose to the grindstone and figured out a way to push AI forward in medicine in a really meaningful way.”
Christine McGuigan is the Managing Editor of Silicon Prairie News.