Ventripoint's VMS+ 4.0 Receives FDA Clearance, Enhancing Cardiac Imaging
Toronto, Ontario -- February 27, 2025 -- NewsGenie -- Ventripoint Diagnostics Ltd. (TSXV:VPT; OTC:VPTDF) has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the VMS+™ 4.0 Automated Radiological Image Processing Software/System.
VMS+ 4.0 includes:
- AI-assisted automated point placement
- Magnet-free sensors
- User tools for cardiac view analysis
- Enhanced visualization tools
- Measurements from 3D wire mesh (ED Volume, ED Volume Index, ES Volume, ES Volume Index, Ejection Fraction, Cardiac Output, Cardiac Index, Stroke Volume, Stroke Volume Index)
- Reporting of measurements and derived parameters
The magnet-free sensors enable VMS+ 4.0 to be used for patients with cardiac pacemakers, benefiting an estimated 3 million people in the U.S. who cannot undergo MRI. VMS+ reports volumes and ejection fractions for all four heart chambers with accuracy comparable to MRI.
The VMS+ 4.0 system connects to standard echocardiography machines and uses Ventripoint’s Knowledge Based Reconstruction technology to create 3D heart images and calculate volumes and ejection fraction for all four cardiac chambers. It can potentially reduce the need for MRI in both children and adults.
Ventripoint President and CEO, Hugh MacNaught, stated, "AI enhanced echocardiograms are a fast, affordable and accessible tool for diagnosis and monitoring of the growing numbers of cardiac patients in America and worldwide.”
VMS+ 4.0 has also received regulatory clearance in the E.U., U.K., and Canada. Earlier versions are used by leading hospitals in the U.S., E.U., U.K., and Canada.
Ventripoint is focused on AI in echocardiography. Ventripoint's VMS+ products are powered by its Knowledge Based Reconstruction technology, providing cardiac measurements equivalent to MRI. VMS+ is versatile and compatible with ultrasound systems from various vendors, supported by regulatory approvals in the U.S., Europe, and Canada.