(via TheNewswire)
Toronto, Ontario / TheNewswire / May 31, 2019 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company", TSXV:VPT, OTCQB:VPTDF) is pleased to announce that they have achieved a major milestone by successfully passing the EMC/Safety Testing for the VMS+ 3.0, which is required for regulatory premarket approvals in Canada, United States and Europe.
"We are very proud of this latest achievement, which was the final piece of testing required for our submissions to the FDA, Health Canada and CE. We anticipate submitting for regulatory approvals for the VMS+ 3.0 shortly," commented Desmond Hirson, Ventripoint President.
The VMS+ 3.0 is a breakthrough cardiac diagnostic tool designed using Artificial Intelligence to create 3D volumetric measurements & ejection fractions from standard 2D Echo for all four chambers of the heart.
Electrical Safety and Essential Performance Testing for the VMS+ 3.0 is based on the following International Electrotechnical Commission (IEC) standards:
IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
They define the specific standards for basic safety and essential performance with regards to electrical safety, mechanical safety, and electromagnetic disturbances for medical electrical equipment.
The VMS+3.0 system is not commercially available for sale. For investigational use only.
About Ventripoint Diagnostics Ltd.
Ventripoint's technology is a leading Artificial Intelligence (AI) approach known as Knowledge-Based Reconstruction (KBR), used 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
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.
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
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