FDA clears VidiStar's nuclear software

PACS developer VidiStar has announced U.S. Food and Drug Administration (FDA) 501(k) clearance of its HeartView nuclear software.

The HeartView software is an Internet-based application intended for use by nuclear medicine technologists, radiologists, and cardiologists. HeartView offers automated processing, remote reviewing, quantification, and multidimensional perspectives of SPECT and tomographic nuclear images.

HeartView is designed to implement algorithms for automatic quantification of myocardial perfusion SPECT as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images, the firm said. Gated results are presented as 3D plots that can be used to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes, including quantitative assessments of cardiac function.

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