Ventripoint Diagnostics is pleased to announce that it has submitted its next generation of software and hardware, VMS+4.0, for approval under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR.
The Company has received notification its submission is complete and is now under active review by the notified body and expects approval in November This marks a significant step forward in the regulatory approval process for this new version of VMS+, which reduces the need for manual inputs and more easily integrates with clinical workflow through further AI-powered automation.
“As more hospitals look to Ventripoint to provide advanced whole-heart analysis, this MDR submission is an important next step in the development and commercialization of the VMS+ family of devices” said Ventripoint President and CEO, Hugh MacNaught. “Upon approval we will be able to provide European cardiologists and care providers with one of the simplest, most-advanced, non-invasive heart-imaging tools available.”
Ventripoint’s VMS+ uses AI to transform ultrasound scans, taken in minutes, into high-quality images of all four chambers of the heart that is a faster and cheaper alternative to MRIs. The technology is now in use in hospitals in the U.S., Europe, the UK and Canada.
The VMS+4.0 has received a Medical Device License from Health Canada and is being offered to leading hospitals within Canada. Ventripoint submitted VMS+4.0 for clearance by US-FDA and has received a first office response, which requested additional information. The Company is actively addressing these questions and expects to submit a detailed package by the end of the year.
EU MDR is the European Union Medical Device Regulation 2017/745 that was adopted in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
