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: email@example.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:
This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends” and similar expressions are intended to identify forward-looking information or statements. The forward-looking statements and information are based on certain key expectations and assumptions made by the Corporation. Although the Corporation believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information because the Corporation can give no assurance that they will prove to be correct. Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Other factors, which could materially affect such forward-looking information are described in the risk factors in the Corporation’s most recent annual management’s discussion and analysis that is available on the Corporation’s profile on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements included in this news release are expressly qualified by this cautionary statement. The forward-looking statements and information contained in this news release are made as of the date hereof and the Corporation undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
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