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HeartFlow Cleared To Launch Non-Invasive FFR Software In U.S.

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.

The first non-invasive fractional flow reserve technology for assessing coronary artery blockages gained FDA go-ahead Nov. 26.

The agency granted market access to HeartFlow Inc.'s fractional flow reserve-computed tomography (FFR-CT) software via de novo classification, clearing the path for the Redwood City, Calif., firm to proceed...

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