VPTDF - Ventripoint Applies to US FDA for Market Clearance for the VMS+ Whole-Heart Analysis System
(via TheNewswire)
Toronto, Ontario / TheNewswire / January 17, 2018 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company", TSXV:VPT) is pleased to announce that it has submitted a traditional 510(k) application to the FDA's Center for Devices and Radiological Health (CDRH) to request clearance for sale of the VMS+ whole-heart analysis system.
"Once again, I commend our regulatory and development teams for this milestone event," stated Dr. George Adams, CEO of Ventripoint. "The Company is focused on making cardiac ultrasound assessments faster, easier and available to all to overcome the costs, delays and limitations of cardiac MRI."
The Company has submitted a new FDA 510(k) to extend the capabilities of our current model to all 4 chambers of the heart. The submission uses the existing VMS as the predicate device and provides testing data to show that the databases for the left atrium, right atrium and left ventricle perform equally well in assessing the chamber volumes in a wide variety of heart conditions, and shapes and sizes of hearts. The volumes and ejection fraction determination by VMS+ were equivalent to MRI measurements, which is the gold standard for these types of cardiac assessments. The data also demonstrate excellent reproducibility between operators.
The submission references the data wherein Ventripoint assessed and measured the safety, quality, and performance of the product. As previously announced (See NR December 19, 2017) the VMS+ device has passed the ISO 60601 testing.
About Ventripoint Diagnostics Ltd.
Ventripoint's technology is a leading Artificial Intelligence (AI) approach known as Knowledge-Based Reconstruction (KBR) to create applications to monitor heart disease, a leading cause of death worldwide. The VMS+ is the first cost-effective and accurate AI tool for measuring whole heart function using conventional ultrasound. The Company has developed a suite of applications for all major heart diseases and is actively commercializing the approach to improve cardiac care.
For further information, please contact:
Dr. George Adams, CEO telephone: (519) 803-6937 email: gadams@ventripoint.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements:
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