//FDA Approves AI Device in an Industry First
May 1, 2018

FDA Approves AI Device in an Industry First

The FDA has approved the first medical device to diagnose disease without a doctor. This isn’t necessarily the first FDA-approved artificial intelligence (AI) device — quite a few others have claimed that before — but it is the first to use AI to deliver a diagnosis.

The IDx-DR uses an AI algorithm to analyze images of the retina and diagnose “more than mild diabetic retinopathy.”

The FDA announced that:

“IDx-DR is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.”

IDx-DR is marketed by IDx, an Iowa-based startup founded by University of Iowa researchers.

Upon the approval, FDA commissioner Scott Gottlieb tweeted the following, which some believe implies that the FDA will approve more AI devices soon (boldface added):

“Artificial Intelligence (AI) and Machine Learning (ML) hold enormous promise for the future of medicine. FDA is taking steps to promote innovation and support the use of artificial intelligence based medical devices. / We’re moving toward using pre-cert approach for AI software that needs to continue to learn and improve as it’s used. We’re developing an efficient regulatory approach for review of AI algorithms used to diagnose and treat disease.”

It’s likely that Gottleib is referring to the FDA Digital Health Software Precertification Program that Intouch learned about, and covered (see our story) at SXSW this year. This program is working with nine companies to explore ways to fast-track digital health solutions. The companies include major pharma players like Johnson & Johnson and Roche; tech giants like Apple, Fitbit, Samsung and Verily; and smaller players like Pear Therapeutics, Phosphorus, and Tidepool.

As AI becomes more prevalent, and more capable, we’ll see more and more examples of it in healthcare, helping to diagnose, treat, and prevent disease faster, more effectively, and more accurately than humans could alone. We’re encouraged by the FDA’s work to develop new ways of bringing these vital solutions to patients and doctors. Check back to learn more as we stay on the watch!