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Season 2: 013 - IDx AI-Based Software for Diabetic Retinopathy
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In this episode, I talk with Michael Abramoff, MD, PhD, founder, president, and director of IDx (https://www.eyediagnosis.net/idx-dr). His company has developed an automated diabetic retinopathy (DR) diagnostic solution, IDx-DR, which received expedited review under the FDA’s Breakthrough Devices program following a pivotal clinical trial. The trial was conducted at ten primary care sites across the U.S., and included about 900 subjects who underwent the IDx-DR exam. Last month, the FDA permitted marketing of the software program, which uses AI to determine whether further followup for DR is needed.
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. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm
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