FDA Clears Inovytec’s Mobile Ventilator Systems

The FDA has granted 510(k) marketing clearance for Inovytec’s Ventway Sparrow transport and emergency ventilators.

The systems weigh only 2.2 pounds and can be used to perform invasive and noninvasive ventilation in patients weighing more than 11 pounds. The ventilators come in three models: a unit compatible with magnetic resonance imaging (MRI) equipment, a military-grade unit and a model designed for emergency services.

The ventilators feature a built-in turbine that removes the need for an external oxygen supply, and they have internal batteries that allow them to run for up to 4.5 hours.