FDA Proceeds To Substantive Review Of VentriPoint’s Pulmonary Arterial Hypertension Detection Device

In short

The U.S. FDA has told VentriPoint Diagnostics that an administrative acceptance review of its 510(k) submission for premarket notification for right heart analysis in Pulmonary Arterial Hypertension (PAH), was found to contain all of the necessary information needed to proceed with the substantive review.

Background

VentriPoint is a developer of diagnostic tools to monitor patients with heart disease, a leading cause of death in developed countries. It claims VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. VentriPoint’s system bases its assessment on a comparison between right ventricle dimension, a key indicator of heart failure, with a library of disease-specific hearts. Dimensional data is acquired easily and quickly from the patient using a series of dots placed on ultrasound views of the heart.

With increasing availability of effective therapies, and evidence-based treatment guidelines recommending starting treatment early, tests enabling detection of PAH as early as possible should prove invaluable. And this is where VentriPoint expects its technology to fit nicely.

Regulatory status

The VMS™ remains for investigational use only in the United States, but is approved for clinical use in Canada and Europe.

Source: VentriPoint Diagnostics, Inc., Marketwire