HeartFlow wins FDA OK for non-invasive FFR system

The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.

By Brad Perriello and Mark Hollmer

Food & Drug Administration (FDA), HeartFlow

News Well, MassDevice Q&A, De Novo Clearance, Regulatory/Compliance

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