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Kidney disease AI diagnostic gets FDA Breakthrough Device designation

May 3, 2019

A Mount Sinai Health System startup, seeking to commercialize an artificial intelligence-enabled clinical diagnostic for kidney disease, has been granted priority regulatory review by the Food and Drug Administration.

The FDA has designated RenalytixAI’s KidneyIntelX as a Breakthrough Device, effectively fast-tracking its development, assessment and review.

The agency’s Breakthrough Devices Program—a voluntary program first authorized in late 2016—is intended to preserve the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, while providing timely access to new solutions for treating or diagnosing a disease or condition that have significant advantages over existing treatment or diagnostic alternatives.

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