HeartIT’s Products Receive CE Mark as Class II Medical Device
July 29, 2016 – Heart Imaging Technologies,LLC (HeartIT) today announced that it has received approval to market its software for making primary medical diagnoses across the European Union. The new CE Mark, Number CE 643954, certifies HeartIT’s WebPAX product family as a Class II medical device. The approval includes HeartIT’s flagship product, WebPAX, as well as its Precession product, which focuses on cardiovascular magnetic resonance imaging (CMR).
According to HeartIT’s Manager of Software Development, Grayson Street, “This new version of our software brings advanced workstation functionality into a bare bones web browser, including tools for quantifying cardiac ejection fraction, blood flow velocities, T1/T2 relaxation times, and even 3D multi-planar reconstruction. In addition, with a single mouse click the workstation measurements can be transmitted directly into the official report, for subsequent transmission to the hospital EMR via our HL7 messaging engine. For CMR, the only thing we don’t provide is the MRI scanner (!)”
Bilal Mir, Senior Account Manager at HeartIT added: “Now physicians can not only view images from anywhere, but they can save significant costs by retiring their expensive desktop-based workstations. All you need is a modern web browser to bring your entire team into a collaborative workspace, where physicians and technicians can see each other’s work in real time regardless of their location. Having all of your workstation tools, not to mention the associated clinical reports, available in a bare bones web browser is an unprecedented advantage for busy physicians and their staff.”
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About Heart IT
Founded in 2000 and headquartered near North Carolina’s Research Triangle Park, Heart IT is a global leader in the medical image web enablement field. Heart Imaging Technologies was the first company to offer a FDA approved zero foot-print medical image workstation which has become the precedent for other companies seeking FDA approval. HeartIT provides web-based medical image management technology and services to health care systems, large hospitals and private clinics as well as drug and device companies sponsoring multi-center clinical trials. Worldwide, Heart Imaging Technologies solutions provide secure web browser access to over one billion medical images. For more information visit our website at www.heartit.com.