IDx: AI Meets Market Access with a Breakthrough Diabetic Retinopathy Detection Device

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Each year, more than 24,000 Americans go blind from diabetic retinopathy. IDx Technologies has been on a decades-long quest to prevent this devastating outcome with a first-of-its-kind, low-cost, autonomous artificial intelligence (AI) diagnostic system. With one of the first devices to gain approval via FDA’s Breakthrough Device Program, the company is also helping to forge a new FDA pathway for AI in medtech, and it is pursuing a more AI-targeted reimbursement model.

More than 30 million Americans have diabetes, and an estimated 24,000 lose their vision each year from diabetic retinopathy (DR), the most common form of eye disease in these patients and the leading cause of blindness in working-age Americans.


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