VentriPoint Diagnostics, creator of the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function, announced that the U.S. Food and Drug Administration (FDA) responded to its Pulmonary Arterial Hypertension (NYSE:PAH) 510(k) submission with a short list of suggestions, clarifications and requests for additional information.
"We are very pleased the FDA has reviewed our submission so expeditiously and we now have a small number of modifications to the filing to prepare," said, Dr. George Adams, CEO of VentriPoint.
Known as the most serious form of the five recognized groups of pulmonary hypertension, PAH is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. The disease affects individuals of all ages, even infants. Although quickly applying treatment helps, most patients with PAH are diagnosed too late for any therapy to be fully effective.
The VMS™ analysis system is currently for investigational use only in the United States and approved for clinical use in Canada and Europe. VentriPoint designed this system to be used for all major heart diseases, including pulmonary hypertension, cardiovascular disease, and heart failure. Offering better efficiency and cost savings, VMS™ offers the healthcare industry a superior method of heart visualization.
For more information on VentriPoint and VMS™, visit ventripoint.com
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