Ventripoint Passes Regulatory Inspection of Manufacturing Facility and Audit of Quality Assurance System
Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”), (TSXV:VPT); (OTC:VPTDF) is pleased to announce the Company has completed another successful NRTL inspection of their manufacturing facility for the manufacture of the VMS+ 3.0.
A Nationally Recognized Testing Laboratories (NRTL) is an independent, third-party organization recognized by the United States Occupational Safety and Health Administration (OSHA) and by the Standards Council of Canada (SCC) that evaluates, tests, and certifies electrical products. Ventripoint has had the NRTL certification for over one year and due to successful quarterly inspections in the first year, is now only required to have bi-annual inspections. This certification signifies the conformance of the VMS+ 3.0 with the applicable electrical safety standards required to sell in Canada and the United States.
The Company has also successfully passed an MDD 93/42/EEC-Annex II audit for EC Certification of their Quality Assurance System. This audit involved a comprehensive review of the CE Marking Technical File of the VMS+ 3.0 by its Notified Body for compliance with the Essential Requirements of the European Union. This certification is a requirement for compliance with the EU Medical Devices Directive 93/42/EEC and will allow Ventripoint to continue to sell its products in the 27 Member States of the European Union.
“Ventripoint is committed to maintaining the highest standard when it comes to the quality and safety of our products and maintaining compliance with regulations. This commitment is important to us so that our customers can have full confidence in our products,” stated Dr. George Adams, Executive-Chairman of Ventripoint.
About Ventripoint Diagnostics Ltd.
Ventripoint has become an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint’s VMS products are powered by its proprietary KBR technology, which is the result of a decade of development and provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold-standard alternative allows cardiologists greater confidence in the management of their patients. Providing better care to patients serves as a springboard and basic standard for all of Ventripoint’s products that guide our future developments. In addition, VMS+ is versatile and can be used with all ultrasound systems from any vendor supported by regulatory market approvals in the U.S., Europe and Canada.
For further information, please contact:
Dr. George Adams
gadams@venripoint.com
519-803-6937
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news 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 Company. Although the Company 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 Company 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. Factors which could materially affect such forward-looking information are described in the risk factors in the Company’s most recent annual management’s discussion and analysis that is available on the Company’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 Company 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.