Wayne, N.J.-based Getinge announces that the U.S. FDA has cleared its Servo-air mechanical ventilator for use on adult and pediatric patients. Servo-air is a high performing ventilator that includes both invasive and noninvasive (NIV) ventilation modes, including high-flow therapy and Servo Compass options. Various modes allow clinicians to adapt and personalize ventilation to the patient and situation.
Eric Honroth, Getinge’s president, North America, calls the product clearance a game-changer for the device. “The FDA 510(k) clearance for Servo-air will broaden our U.S. offering with a turbine-driven ventilator, he adds. “Servo-air has the same proven easy to use interface with the same context-based guidance as the Servo-u ventilator.”
Servo-air is turbine-driven and independent from wall gas, which allows for uninterrupted ventilation for intensive care patients. Moreover, Servo-air is suited for intra-hospital transport, intermediary, or intensive care. Finally, dual, hot swappable batteries allow set up anywhere in the intensive care unit, with strong performance and
“In partnership with intensive care clinicians, Getinge;s Servo-air can help save lives in the U.S. market,” Honroth says. The device is slated for availability in the U.S. in late 2020.