VentriPoint Diagnostics has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking approval for its 2D-ultrasound system, designed for measuring right ventricle heart function in patients with pulmonary arterial hypertension (PAH).
The VMS heart analysis system, which is available in Canada and Europe, enables physicians to quickly and non-invasively determine the size and function of the right heart, allowing to improve patient care and reduce healthcare costs.
VentriPoint Diagnostics CEO George Adams said the submission represents the culmination of combined efforts of the company and the support of its clinical collaborators at cardiac centers in the US, Europe and Canada.
"I would like to thank Dr. Scott Solomon and his team at Harvard Brigham & Women”s Hospital for performing the core-lab analysis in the clinical trial, which compared VMS™ to conventional cardiac MRI." Adams added.