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Medical Devices / Submissions and Approvals

Vyaire Earns FDA Clearance for Ventilator System

Nov. 8, 2019

Vyaire Medical has received 510(k) clearance for its Bellavista 1000e, an intensive care unit ventilator designed for use in patients ranging from premature neonates to adults.

The ventilator features a high definition touchscreen and an adaptive ventilation mode, which measures the patient’s lung mechanics and adapts to their needs by calculating the optimal ventilation pattern at the lowest possible pressure.

The Bellavista 1000e also features high flow oxygen therapy that works alongside an actively humidified tubing system to improve patient oxygenation and comfort.

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