(TheNewswire)
Toronto, Ontario – TheNewswire - October 8, 2024 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTCQB:VPTDF) is pleased to announce the successful completion of three important quality audits, which were required to continue sales of the existing VMS+ models as well as to submit the newest version, VMS+4.0, for European Union review. All audits resulted in positive outcomes and demonstrated the company's commitment to upholding the highest standards in quality, safety, and regulatory compliance. The audits were conducted by third-party auditing organizations and addressed:
MDSAP (Medical Device Single Audit Process)
The MDSAP audit insures compliance with the medical device regulatory requirements of multiple jurisdictions, including the U.S. and Canada. This program streamlines the regulatory process, allowing Ventripoint to maintain certifications across these key markets efficiently.
ISO 13485:2016 Certification
ISO 13485:2016 is the globally recognized standard for quality management systems specific to the medical device industry. Passing this audit validates our comprehensive quality system, ensuring consistent performance, safety, and product quality.
MDR 2017/745
The successful audit under the European Union's MDR 2017/745 demonstrates that Ventripoint's products meet the rigorous new regulatory standards governing medical devices in the European market. This regulation focuses on patient safety, product traceability, and post-market surveillance, ensuring a high level of safety and performance for all medical devices sold in Europe.
“These milestone achievements demonstrate Ventripoint’s dedication to maintaining a robust quality management system and ensuring that its products meet the stringent requirements for medical devices of key international regulatory bodies. They are an important step as we position the company for growth” said Ventripoint President and CEO, Hugh MacNaught. “We believe that the advancements incorporated into VMS+4.0 improve the attractiveness of the technology and our team has worked to ensure that our processes will enable our ability to meet increased demand in Q4 and beyond.”
About Ventripoint Diagnostics Ltd.
Ventripoint is an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint's VMS products are powered by its proprietary Knowledge Based Reconstruction 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:
Hugh MacNaught
hmacnaught@ventripoint.com
604-671-4201
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.
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