FDA Clearance of New Pulmonary Function Testing Technology

Tuesday, September 24, 2019

Vyaire Medical, Inc., the healthcare industry’s dedicated “breathing company,” today announced the U.S. Food and Drug Administration (FDA) has granted FDA 510(k) clearance for two of its latest Pulmonary Function Testing (PFT) technologies: Vyntus ONE, Vyntus BODY with SentrySuite Software.

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.

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.”

Vyaire believes this product launch represents the most progressive innovation in the Respiratory Diagnostics field in many years. Vyntus ONE and Vyntus BODY are the continued expansion of the portfolio – including Vyntus CPX, Vyntus SPIRO, Vyntus WALK, and Vyntus ECG – all of which run on the SentrySuite Software platform.

FDA Clearance  of New Pulmonary Function Testing Technology
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