The US FDA has granted FDA 510(k) clearance for two of Vyaire Medical’s new pulmonary function testing (PFT) devices, Vyntus One and Vyntus Body with SentrySuite software, according to the company.
The Vyntus One is designed to be a convenient PFT station available in a fixed or mobile configuration that is patient-friendly and easy for clinicians to use.
Vyntus Body is engineered to conduct body plethysmography to measure lung capacity and other pulmonary functions for patients of all sizes and mobility, offering larger interior space to accommodate patients of any size without increasing the footprint of the cabin.
Both Vyntus One and Vyntus Body include a newly designed Ultrasonic Flow Sensor that represents significant improvements in efficiency and accuracy of pulmonary function testing, Vyaire reports.
All Vyntus technologies run on the SentrySuite Software, which is easy-to-operate and designed completely around the user experience for accurate results and optimal workflow. SentrySuite provides seamless integration and secure connectivity with both the clinical infrastructure and the electronic medical records (EMR) platform.
“These new Vyntus products offer a modern ergonomic design, state-of-the-art ultrasonic sensor technology for consistent and accurate respiratory testing as well as more efficient hygiene and maintenance protocols for customers.” said Dave Eckley, Vyaire’s Chief Executive Officer. “These benefits are absolutely meaningful in today’s respiratory diagnostics clinical environment and demonstrate the value of the Vyaire technologies.”