VentriPoint Diagnostics Receives Health Canada Regulatory Approval | VentriPoint Diagnostics Ltd.
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Healthcare Company News VentriPoint Diagnostics Ltd. VentriPoint Diagnostics Receives Health Canada Regulatory Approval

VentriPoint Diagnostics Receives Health Canada Regulatory Approval

Company News - VentriPoint Diagnostics Ltd.

VentriPoint, Inc. has been granted a medical device license by Health Canada to sell and market its VentriPoint Medical System

VentriPoint Diagnostics Ltd. (the "Corporation") (TSX VENTURE:VPT) has made the significant announcement that its wholly-owned subsidiary, VentriPoint, Inc. ("VentriPoint") has been granted a medical device license by Health Canada to sell and market its VentriPoint Medical System ("VMS") to provide key measurements and accurate reconstructions of the right ventricle of a patient's heart from standard two-dimensional ultrasound images.
ventripoint-dianostic-system
"This regulatory milestone is a major advancement in VentriPoint's efforts to provide cost effective monitoring and treatment for patients with heart disease. Having achieved this milestone VentriPoint can proceed with its commercialization plans to introduce the VMS diagnostic tool for Canada's congenital heart disease population and to advance its use for other heart diseases, including pulmonary hypertension," stated Joe Ashley, President & CEO of the Corporation. "The availability of the VMS to quickly and inexpensively provide critical information of a patient's right ventricle is expected to help enable Canadian healthcare organizations to better monitor and treat patients suffering from heart disease."

Concurrently, VentriPoint also announced today that its Quality Management System, which covers the design and development of its VMS, has met the requirements of the ISO 13485:2003 standard. This certification was obtained following a successful audit in January 2009 by Intertek Testing Services NA Ltd. This certification is an internationally recognized management system standard developed by the International Organization for Standardization (ISO). "The certification is an important measure of the Company's quality capabilities. ISO certification is another significant achievement for VentriPoint and reflects our commitment to excellent performance in our internal design and manufacture of the VMS," said Scott Ashley, Vice President of Research & Development. "Our proven quality management system will facilitate regulatory approvals of our products on a global basis."

About VentriPoint Diagnostics Ltd.

VentriPoint creates diagnostic tools to monitor patients with heart disease - the number one cause of death in developed countries. By using images produced from existing medical imaging systems, the VentriPoint Medical System ("VMS") generates critical heart measurements in a rapid and inexpensive manner not currently available. Health Canada has granted licensed approval for the VMS breakthrough diagnostic tool which is based upon technology received by VentriPoint through its exclusive technology license with the University of Washington. The VMS, together with its associated online service, is being expanded to cover a variety of heart related disease states, including congenital heart disease.

Source: http://www.ventripoint.com