Vyaire Medical Receives FDA 510(k) Clearance for Two Innovative Pulmonary Function Testing Systems: Vyntus ONE and Vyntus BODY

On August 21, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that medical device company Vyaire Medical announced that its latest two pulmonary function testing (PFT) technologies, Vyntus ONE and Vyntus BODY, had received FDA 510(k) clearance.

Pulmonary function testing encompasses ventilation, gas exchange, respiratory regulation, and pulmonary circulation functions, involving numerous test items and measurement indices. Historically, pulmonary function instruments primarily relied on mechanical and chemical methods, which were cumbersome, time-consuming, labor-intensive, and prone to significant measurement errors. These limitations restricted their widespread clinical application and resulted in limited familiarity with such testing among healthcare professionals.

In recent years, with the advancement of science and technology and the emergence of new testing techniques, particularly the application of computers, pulmonary function testing has undergone significant development, and its clinical importance has received increasing attention.

Vyntus ONE is designed as a convenient PFT workstation that can be either stationary or mobile, facilitating use by both patients and clinicians. Vyntus ONE provides spirometry, DLCO (diffusing capacity of the lung for carbon monoxide), and nitrogen washout lung volume measurement.

The Vyntus BODY enables body plethysmography to measure patients’ lung volumes and other pulmonary function parameters. Its spacious interior accommodates patients of all sizes without increasing the cabin’s footprint. Both the Vyntus ONE and Vyntus BODY incorporate a newly designed ultrasonic flow sensor, which significantly enhances the efficiency and accuracy of pulmonary function testing.

Both Vyntus ONE and Vyntus BODY operate on the company’s proprietary SentrySuite software, which is designed for ease of use and centered on user experience to deliver accurate results and optimize workflow. SentrySuite integrates seamlessly with clinical infrastructure and electronic medical record (EMR) platforms, ensuring secure connectivity.

Vyaire Medical believes that the launch of Vyntus ONE and Vyntus BODY represents the most significant innovation in the field of respiratory diagnostics in years. The company’s extended product portfolio, including Vyntus CPX, Vyntus SPIRO, Vyntus WALK, and Vyntus ECG, also operates on the Sentry Suite software platform.

“These new Vyntus products feature modern ergonomic design, advanced ultrasonic sensor technology, and accurate respiratory testing, enabling better service to our customers,” said Dave Eckley, CEO of Vyaire. “These benefits are highly relevant in today’s clinical environment for respiratory diagnostics and further demonstrate the value of Vyaire’s technology.”

Vyaire Medical, established in October 2016 and headquartered in Chicago, Illinois, USA, is a global medical device company. Vyaire Medical is committed to providing healthcare services to patients and improving their quality of life. The company was founded to deliver innovative equipment and medical service solutions to healthcare clients, with its product portfolio spanning the respiratory and anesthesia sectors.

From industry-leading brands, including Bird®, Bear®, and Jaeger®, to exceptional product lines such as AirLife™, Vital Signs™, and Viasys®, along with many other brands, Vyaire Medical offers nearly 27,000 distinct products that are recognized, trusted, and preferred by respiratory care and anesthesiology healthcare professionals worldwide.

(Compiled by Cheng Tao)