FDA OKs Medis quantitative cardiac software

Medical imaging software developer Medis Medical Imaging Systems has received clearance from the U.S. Food and Drug Administration (FDA) for its QAngio XA 3D software (QFR) for the quantitative analysis of peripheral and coronary vessels.

QFR is based on standard x-ray angiographic images and direct coronary flow estimation, which provide results during procedures. The software is designed to be vendor neutral and to be used on both biplane and monoplane x-ray angiographic imaging systems. Image selection is performed through an angiographic acquisition guide, with total analysis time between four and five minutes including image frame selection.

QFR also is intended to help clinicians reduce stent overuse and associated risks, better determine the correct stent length and landing zones, and help establish optimal viewing angles for stent positioning, according to the company.

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