Getinge receives 510(k) clearance for Servo-air® mechanical ventilator
US Food & Drug Administration (FDA) clears Servo-air® mechanical ventilator for use with adult and pediatric patients dependent on intensive care ventilation expanding upon the Servo family of products available in the United States for decades.
"FDA 510(k) clearance for Servo-air will broaden our US offering with a turbine driven ventilator," says Eric Honroth, President, North America at Getinge. "The Getinge Servo platform holds a leadership position in the US marketplace, further expanding Getinge’s global ventilation business."
Servo-air is a high performing ventilator intended for adult and pediatric patients, and includes both Invasive and Non-Invasive (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.
Honroth 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 that allows for powerful, uninterrupted, quiet ventilation benefitting the intensive care patient. Servo-air is ideally suited for intra-hospital transport, intermediary, or intensive care. Dual, hot swappable batteries allows set up anywhere in the intensive care unit with powerful performance and optimal endurance. Mechanical ventilation is a key component in the ongoing fight against COVID-19.
"In partnership with intensive care clinicians, Getinge’s Servo-air can help save lives in the US market," Honroth concludes.
Servo-air is expected to be available in the US in late 2020.