Ventripoint Manufacturing Facility Passed Inspection and First Two
VMS+ 3.0 Heart Analysis Machines Shipping to Western Canada
Toronto, Ontario, July 31, 2019 – Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”,
TSXV:VPT, OTCQB:VPTDF) is pleased to announce that its manufacturing facility for the VMS+ 3.0
whole heart analysis system received its initial inspection and passed on July 25th, 2019. The first two devices are being fabricated and are on schedule to ship this week to fulfill purchase orders at a Heart Institute and a Children’s Hospital in Western Canada (see Ventripoint News Releases from July 15th & 16th, 2019).
“Delivery of the first next-generation VMS+ devices is a major milestone for Ventripoint and its mission to improve cardiac diagnosis and care worldwide,” commented Desmond Hirson, President of Ventripoint.
Before medical electrical equipment can be used or sold, it must be approved by an accredited
certification agency and must carry the official mark of that agency. This indicates that the product has been independently assessed for safety and every unit is fully tested for electrical safety before release. As part of this process, the production facility from which the device is being manufactured must undergo a facility inspection by an OSHA-recognized Nationally Recognized Test Lab (NRTL). This is a requirement for Canada and the United States.
The internal manufacturing facility for the VMS+ 3.0 system passed the inspection with positive results i.e. no non-conformities. This will enable the fabrication of VMS+ 3.0 devices from the Ventripoint facility.
The VMS+ 3.0 system is commercially available in Canada and Europe. The system is for
investigational use in the United States and pending pre-market 510K clearance by the FDA.
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.
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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