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Cardiac blood flow software gets FDA nod

December 9, 2014
by Richard R. Rogoski
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A non-invasive software solution that measures blood flow through the heart has been cleared by the U.S. Food and Drug Administration (FDA). The HeartFlow FFR-CT software, developed by Redwood City, Calif.-based HeartFlow Inc., allows healthcare providers to evaluate blood flow in the coronary arteries to check for coronary artery disease without invasive procedures.

In determining a key value called fractional flow reserve, the software uses data from a computed tomography (CT) scan of the heart. Using this data and other clinical data, the healthcare provider can determine whether flow rate is below acceptable limits and whether cardiac catheterization is necessary.

"HeartFlow FFR-CT is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data," said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. "This non-invasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures."