Digital Diagnostics’ Autonomous AI Technology Clearing Reimbursement and Payor Hurdles

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The company’s autonomous AI diabetic retinopathy diagnostic system has received a CMS proposed coverage rule that goes into effect January 1. It is now working toward a fair, cost-saving reimbursement rate, and to rigorously validate its precedent-setting technology.

It’s an exciting time in the field of artificial intelligence (AI)-based medical devices, with potentially transformational progress that promises to improve patient access to care, increase quality of care, eliminate healthcare disparities, and lower costs, in a wide variety of medical procedures and conditions. Radiological imaging is the frontrunning segment in this space, with devices entering the market intended to automate the diagnostic radiology workflow as well as guide image acquisition.

Market Pathways has been tracking the upward trajectory of a trailblazer in this arena, IDx Technologies, recently rebranded as Digital Diagnostics Inc. The Coralville, IA-based company’s IDx-DR is the first and only FDA-approved autonomous AI diagnostic system for the detection of diabetic retinopathy (DR) and macular edema. Diagnosing these conditions in their early, symptom-free stages is critical in preventing blindness. More than 30 million Americans have diabetes, only 15% to 50% of patients who need a DR exam are getting one, and an estimated 60,000 lose vision each year from this disease. Digital Diagnostics hopes to shift this standard of care with the first system that provides a medical decision without the need for a clinician to also interpret the image.


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