Tuesday, November 5, 2024

Tuesday, November 5, 2024

VYAIRE MEDICAL: Proven bellavista™ 1000e Ventilator System Receives FDA Clearance


Vyaire Medical, Inc. issued the following announcement on Nov. 6.

Vyaire Medical, Inc.'s bellavista 1000e ventilator has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is the newest addition to Vyaire's high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device. Clinicians can rapidly change therapies on a broad range of patients in an effortless way.

"We began using bellavista exclusively in 2017, when it was available in Europe. It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation," said Vincenzo Cannizzaro, MD, PhD, Deputy Chief Physician of PICU/NICU, University Children's Hospital, Zurich, Switzerland.

Designed exclusively around enhancing the caregiver's experience, the bellavista 1000e's intuitive touch screen provides advanced graphics to easily visualize the patient's pulmonary status, enhancing situational awareness for the caregiver. Whether its escalating care or weaning a patient efficiently, the bellavista 1000e ventilator simplifies the process by delivering optimal workflows with the goal of reducing operator error and ventilator lengths of stays.

"Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances," said Lisa Rose, Chief Marketing and Innovation Officer, Vyaire Medical. "The bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers."

Today, there are more than 8,200 bellavista 1000e ventilators in use across 92 countries outside of the United States. The bellavista 1000e ventilator will be introduced to the U.S. healthcare market at the American Association of Respiratory Care Congress (AARC), November 9—12 2019 in New Orleans at Vyaire Booth #1219.

About Vyaire Medical

Headquartered near Chicago, IL., Vyaire Medical — a global company dedicated to respiratory care — enables, improves and extends lives with an unyielding focus on improving patient outcomes and increasing value for customers. The company was formed in October 2016 to serve healthcare providers with innovative devices and service solutions across the respiratory and anesthesia continua of care.  Vyaire's legacy brands have a 65-year track record of pioneering and advancing respiratory diagnostics, ventilation, and anesthesia delivery & monitoring.  From original brands including Bird, Bear, and Jaeger to industry leaders AirLife™, Vital Signs™, Viasys, and many others — Vyaire Medical is recognized, trusted and preferred by specialists in respiratory and anesthesiology healthcare worldwide.

Original source can be found here.

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