Ventripoint’s VMS+ 4.0 Submitted for Regulatory Approval in China, Qualifies for Expedited Review

Ventripoint Diagnostics Ltd. (TSX-V:VPT, OTC:VPTDF) announced Monday that its strategic partner, Lishman Global Inc., has formally submitted the company’s VMS+ 4.0 system to China’s National Medical Products Administration (NMPA) for regulatory approval. The submission marks a significant step in Ventripoint’s global expansion strategy, particularly given the size and growth potential of the Chinese cardiology market.

Lishman Global qualified for the NMPA’s ‘green channel’ pathway, an expedited review process designed for innovative medical technologies that address significant clinical needs. This designation is expected to streamline the regulatory timeline and facilitate faster access to the Chinese market, according to the company.

China represents a substantial opportunity in cardiology. Cardiovascular disease is the leading cause of mortality in the country, affecting an estimated 330 million patients. Echocardiography is the most widely used cardiac imaging modality due to its cost-effectiveness, portability and scalability across urban and rural settings. However, variability in image interpretation and limited access to advanced imaging such as MRI have created a strong need for AI-driven tools that can improve diagnostic accuracy and workflow efficiency.

Ventripoint’s VMS+ 4.0 addresses this need by providing MRI-equivalent volumetric measurements using standard 2D echocardiography. Powered by the company’s proprietary Knowledge Based Reconstruction technology, the platform enables clinicians to assess all four chambers of the heart with high accuracy, supporting diagnosis and management of conditions such as congenital heart defects, heart failure, pulmonary hypertension, cardiotoxicity and valvular disease.

‘We are excited to take this important step toward bringing VMS+ 4.0 to the Chinese market,’ said Paul Gibson, chief technology officer of Lishman Global Inc. ‘Qualification for the NMPA’s green channel underscores the clinical relevance and innovation of VMS+ 4.0 and provides a clear pathway to accelerated adoption. China’s scale, combined with its increasing focus on improving cardiovascular outcomes, makes it an ideal environment for this technology.’

‘Hitting this regulatory milestone with Lishman Global is a key validation of both our technology and our international strategy,’ said Hugh MacNaught, president and chief executive officer of Ventripoint Diagnostics. ‘China is one of the most important cardiac care markets in the world. With the benefit of an expedited review pathway, we are well positioned to bring VMS+ 4.0 to clinicians and patients more quickly.’

The company will provide further updates as the regulatory review process progresses. Ventripoint’s VMS+ products are already supported by regulatory approvals in the U.S., Europe and Canada, and can be used with ultrasound systems from any vendor.

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