Ventripoint Diagnostics Ltd. announced that its strategic partner, Lishman Global Inc., has formally submitted the VMS+ 4.0 system to China's National Medical Products Administration (NMPA) for regulatory approval. Notably, Lishman Global qualified for the NMPA's "green channel" pathway, an expedited review process for innovative medical technologies addressing significant clinical needs. This designation is expected to streamline the regulatory timeline and facilitate faster market access.
This submission marks a critical step in Ventripoint's global expansion strategy, particularly in China, where cardiovascular disease is the leading cause of mortality, affecting an estimated 330 million patients. Echocardiography is the most widely used cardiac imaging modality in China due to its cost-effectiveness and scalability, but variability in interpretation and limited access to advanced modalities like MRI have created demand for AI-driven tools. VMS+ 4.0 addresses this by providing MRI-equivalent volumetric measurements using standard 2D echocardiography, powered by the company's proprietary Knowledge Based Reconstruction technology. The platform enables accurate assessment of all four heart chambers, supporting diagnosis and management of 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."
Hugh MacNaught, President and CEO of Ventripoint Diagnostics, added, "Hitting this regulatory milestone with Lishman Global is a key validation of both our technology and our international strategy. 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. By enabling more accurate and reproducible cardiac measurements using existing ultrasound infrastructure, VMS+ has the potential to significantly expand access to high-quality cardiac care."
The green channel designation is reserved for products that offer significant clinical advantages, and this submission could set a precedent for other AI-based medical devices entering China. The regulatory process will be closely watched by investors and industry stakeholders, as successful approval could open a substantial revenue stream for Ventripoint. The company plans to provide further updates as the review progresses.
