HeartFlow Cleared To Launch Non-Invasive FFR Software In U.S.
This article was originally published in The Gray Sheet
FDA granted market access to HeartFlow's fractional flow reserve-computed tomography software, the first non-invasive fractional flow reserve technology for assessing coronary artery blockages.
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HeartFlow recently gained FDA go-ahead for its FFR-CT technology, a first-of-its-kind, noninvasive diagnostic test that allows physicians to assess blood flow in patients with coronary artery disease. With more than 25 million patients who could potentially benefit from this test in the US, EU, and Japan alone, the market potential for this technology is enormous.
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HeartFlow anticipates rolling out its computed tomography-based coronary fractional flow reserve software (FFRCT) in the U.S. very soon, following an imminent FDA decision on the system. The firm hopes its cloud-based software system, which relies on advanced computational fluid dynamics algorithms and CT imaging, will offer an enhancement on catheter-based FFR to interventional cardiologists.