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VentriPoint Diagnostics Ltd Announces FDA 510(K) Submission For VMS Heart Analysis System For Pulmonary Arterial Hypertension

Thursday, 31 Jan 2013 06:40pm EST 

VentriPoint Diagnostics Ltd announced that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first 2D-ultrasound right-heart analysis system in patients with Pulmonary Arterial Hypertension (PAH). The VMS heart analysis system will enable physicians to quickly and non-invasively determine the size and function of the right heart - transforming patient care and reducing healthcare costs. Right heart function remains one of the prognostic parameters in PAH. The VMS is approved for clinical use in PAH patients in Canada and Europe and is for investigational use only in the United States. 

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