Ventripoint Successfully Completes European Commission QMS Certification Surveillance Audit
Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”), (TSXV:VPT; OTC:VPTDF) is pleased to announce that is it has successfully completed a surveillance audit of its quality assurance system under Medical Device Directive 93/42/EEC (MDD), Annex II with no findings. This is the first surveillance audit since Ventripoint’s last full recertification (see NR March 9, 2021).
The audit by a EU-based Notified Body confirmed that Ventripoint continues to remain in compliance with the requirements of the European Medical Device Directive. Our continued certification allows us to continue to market in CE Mark European countries, which include the European Economic Area, Switzerland, and, until 2023, the United Kingdom and until Ventripoint transitions to the new EU Medical Device Regulation (MDR).
This significant achievement for the organization is a testament to the commitment of the entire Ventripoint team to designing, developing, manufacturing, and distributing high quality products and improving patient’s lives,” said Dr. George Adams, CEO 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
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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.
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.