Ventripoint Achieves Major Milestone by Passing External Safety
Testing for Next-Generation VMS+ 3.0
Toronto, Ontario, 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.
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