SuperSonic Imagine said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its next-gen Aixplorer Mach 30 ultrasound system.
The France-based company touted that the newly cleared system features its UltraFast imaging and enhanced performance over previous models of the device. The Aixplorer features the company’s SonicPad touchpad interface and improved B-mode image quality.
The Aixplorer Mach 30 also features ShearWave elastography intended to allow for real-time, reliable, quantitative and reproducible 2D and 3D visualization of tissue stiffness.
“The FDA 510(k) and CE Mark are critical milestones in the launch of our exciting new system. These approvals not only confirm that the Aixplorer MACH 30 is recognized for its quality, performance, and compliance with American and European regulatory standards, but it also clears the way for marketing of the system in the US, European member states, and many other countries around the world. We are confident this new innovative platform will offer clinical value which supports our growth ambitions in the Global Ultrasound Market,” CEO Michèle Lesieur said in a prepared statement.
“During clinical evaluations performed in the US, we received enthusiastic customer feedback from those who used the Aixplorer Mach 30 and its touchpad. The SonicPad permits quick and intuitive control of all functions needed for a successful examination. It lets users improve their workflow while concentrating on the analysis of on-screen clinical information rather than which buttons to push for optimal image acquisition. The same enthusiastic reception was observed globally,” chief biz officer Kurt Kelln said in a press release.
In March, Verasonics said it filed a suit against Supersonic Imagine alleging it infringed on Verasonic patents related to software beam forming architecture.