The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health

Thursday, February 26, 2026

Ventripoint Diagnostics Ltd. – We put the heart into A.I.

FDA AND CE APPROVED



 Ventripoint Diagnostics' VMS+ system has received U.S. Food and Drug Administration (FDA) 510(k) clearance [21]. The most recent, VMS+ 4.0 system, received 510(k) clearance in February 2025, which is used to analyze heart chamber volumes and function (ejection fraction) in 3D using 2D ultrasound [22].
Key Details Regarding FDA Status:
  • 510(k) Cleared: The VMS+ system has received 510(k) clearance, indicating it is substantially equivalent to legally marketed devices for measuring heart volume and function [24].
  • Latest Version: The VMS+ 4.0 was cleared in February 2025, featuring AI-assisted, magnet-free technology suitable for patients with cardiac pacemakers [22].
  • Clinical Use: The technology is designed to produce MRI-quality measurements of all four chambers of the heart, with applications in both pediatric and adult cardiac care.
  • Vendor Neutral: The VMS+ system connects to standard ultrasound machines from various manufacturers.

A Breakthrough in Diagnostics for the Heart  With our patented A.I., ultrasound scans are turned into high-fidelity 3D models of all four chambers of the heart, at a fraction of the cost and time of a traditional MRI.

Ventripoint is now being used by major hospitals in Europe, the U.K., the U.S. and Canada.

Our VMS+ is a diagnostic aid that was developed to provide a point of care solution to better communicate the heart’s structure and function without the need for MRI.

The VMS+ marries the ingenuity of the cardiac MRI and Echo with the power of Ventripoint’s Knowledge Base Reconstruction (KBR). KBR powers construction of a 3D model of the heart and calculates volumes and ejection fractions for all chambers with an accuracy comparable to the MRI.


 


Ventripoint Diagnostics Ltd. – We put the heart into A.I.
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