Ventripoint Diagnostics has received an acceptance review notification concerning its recent 510(k) submission to US Food and Drug Administration (FDA) to expand the use of Ventripoint Medical System (VMS) heart analysis system to all types of heart disease.
The notification confirms the submission contains all necessary elements and information needed to proceed with the substantive review, for which a lead reviewer has been assigned.
The FDA guidelines mandate that the company receive its first communication regarding the submission within 60 days, with closure of the submission expected to occur within 90 days.
The submission includes the addition of the company’s newest catalogue, Right Ventricle, which was developed to provide right ventricular volumes of individuals being evaluated, regardless of their cardiac diagnosis.
According to the company, clearance by the FDA will greatly increase the utility and market adoption of the VMS.
Ventripoint CEO Dr George Adams said: "We are extremely pleased with how quickly this process has been going so far, which is a true testament to our development and regulatory team. We look forward to the US-FDA’s response in the next 60 days."
The company developed tools to monitor patients with heart disease and VMS is the first cost-effective and accurate tool for measuring right ventricle heart function.
It has a suite of applications for all major heart diseases and imaging modalities such as congenital heart disease, left or right heart failure and normal hearts.