In a new wrinkle for the integration of artificial intelligence in healthcare, the U.S. Food and Drug Administration has granted health tech business IDx permission to market the first autonomous, AI-based diagnostic system. IDx-DR is designed to automate the detection of diabetic retinopathy, a complication of diabetes, and is intended to be used by primary care physicians
The size of the problem is massive. Many of the more than 30 million Americans who have diabetes are believed to have signs of diabetic retinopathy, according to the FDA.
The marketing clearance follows the FDA’s decision to approve a “breakthrough device” designation for IDx-DR, accelerating the review process for the product based on its ability to address an unmet medical need.
[IDx CEO Gary Seamans is taking part in the upcoming MedCity INVEST conference in Chicago May 1-2. ]
“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, founder and president of IDx, in a company news release. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
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, noted in an FDA announcement that the technology would be especially useful in detecting retinopathy earlier. That’s currently a big hurdle in treating this condition since half of the diabetes patient population do not see their eye doctor on a yearly basis.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In an interview earlier this year, Abràmoff explained how IDx-DR works in a clinical setting. The results are delivered at the point of care — the algorithm behind IDx-DR takes 20 seconds and the total system runs in a matter of minutes. Patients can have their retinas screened prior to their appointment. The doctor can then immediately follow up with an appropriate referral or even a change to the patient’s treatment plan if there are signs that the disease is not being adequately controlled.
IDx’s disruptive technology gives the tools to make clinical decisions to primary care physicians. The FDA’s description noted that a positive result can prompt them to refer patients to an “eye care professional”. It’s an interesting development because much of the attention in the debate over whether AI will replace physicians has focused on the radiology sector. What’s different here, much like the business model some companies in the teledermatology space have pursued, is that IDx’s test is designed to expedite these exams at a primary care level to reduce the potential backlog of patients seeing specialists for these tests first.
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