Updates to submission of VMS+ 4.0 provided to FDA on January 17, 2025
Ventripoint will market new advances in USA after FDA clearance
Toronto, Ontario – TheNewswire - January 21, 2025 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTC:VPTDF) has reached another development milestone by updating the submission of its next generation of software, VMS+ 4.0, to the U.S. Food and Drug Administration (“FDA”) for clearance. The update addresses questions regarding cybersecurity and AI.
This latest advancement of Ventripoint’s proprietary technology, VMS+ 4.0, delivers two significant enhancements to improve clinical workflows
AI-assisted echocardiogram image analysis
Simplified sensors pairing workflow.
These new improvements are in addition to the benefits of VMS+ 3.0
Full-scope use so all patient groups can be easily scanned and assessed.
Magnet-free sensors increasing the scope of patients who can benefit
Vendor-neutral interfacing with any ultrasound machine.
“Ventripoint is a pioneer in the application of AI to echocardiography and VMS+ 4.0 is the result of over two years of research and development,” said Ventripoint President and CEO, Hugh MacNaught. “We are grateful for the collaboration by the Avania team to support this update to our submission. Upon FDA clearance we look forward to offering U.S. hospitals one of the simplest, most effective, non-invasive heart-imaging tools available.”
“Avania is proud to support Ventripoint on this important innovation. As a long-term partner, we have been continually impressed with Ventripoint's progress and the continual improvements they have made to their products,” said Joel Ironstone, VP, Regulatory & Advisory Services for Avania. “We excitedly look forward to working with them on their next innovation.”
Ventripoint updated its submission of VMS+ 4.0 for clearance by the FDA on January 17, 2025 to meet a requirement for significant software and hardware updates and diagnostic advances. VMS+ 4.0 has already secured regulatory clearance in other key markets such as the E.U., U.K. and Canada making this latest version of VMS+ available to the global community. Earlier versions of Ventripoint’s scanning technology received FDA, Health Canada and E.U. regulatory approvals and are being used by leading hospitals in the U.S., E.U., U.K. and Canada.
About Ventripoint Diagnostics Ltd.
Ventripoint is an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint's VMS+ products are powered by its proprietary Knowledge Based Reconstruction 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:
Hugh MacNaught
This email address is being protected from spambots. You need JavaScript enabled to view it.
604-671-4201
About Avania
Avania is the leading global MedTech advisory and clinical development partner with a focus on medical devices, diagnostics/IVDs and digital health.
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 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. 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.
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