VIDISTAR® ANNOUNCES 510(K) CLEARANCE OF HEARTVIEW® SOFTWARE

VIDISTAR® ANNOUNCES 510(K) CLEARANCE OF HEARTVIEW® SOFTWARE

GREENVILLE, SC (DECEMBER 1, 2015) – VidiStar, LLC announces the 510(k) clearance of the nuclear software, HeartView. Based on conformance to FDA recognized voluntary consensus standards, VidiStar provided evidence that the HeartView nuclear processing software is safe, effective, and substantially equivalent to other leading, third party nuclear processing systems.

The HeartView software is one of the first internet-based applications intended for use by nuclear medicine technologists, radiologists, and cardiologists. HeartView offers automated processing, remote reviewing, quantification, and multidimensional perspectives of single photon emission computerized tomography (SPECT) and tomographic nuclear images.

“HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations. Heartview utilizes VidiStar’s patented technology and enables physicians the ability to remotely read a report using the internet. We are proud to be announcing our clearance with 510(k) standards,” explains Craig Walker, founder and CEO, VidiStar.

The intended use of the HeartView software is 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. 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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For sales information contact, Southeast Sales Representative Michael Noland at 864.630.9160, michael.noland@vidistar.com; Territory Manager – Florida Michael Mahoney at 239.777.1066, mmahoney@vidistar.com. For clinical information contact, National Clinical Manager Steve Franks at 888.518.7541, option 3, steve.franks@vidistar.com.

 

ABOUT VIDISTAR, LLC
VidiStar, LLC based in Greenville, SC (USA) has developed a web-based diagnostic viewer and patented structured reporting solution (US Pat. No. 8,200,505) for medical imaging products based on the Digital Imaging and Communications in Medicine (DICOM) standard. VidiStar’s technology enables physicians and health care providers the ability to read and interpret diagnostic studies over local area networks and wide area networks for timely interpretation, distribution and improved patient diagnosis by providing a wide range of clinicians with instant access to superior high-quality images and patient data. VidiStar has extensive experience in integrating with other picture archiving and communications system (PACS) companies as well as electronic health/medical record vendors. For more information, visit www.vidistar.com or call 1.888.518.7541.

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