Getinge Secures FDA 510(k) Clearance for Servo-air® Lite, Expanding Ventilator Offering in the US

Saturday, July 08, 2023

Getinge, a prominent medical technology company, has successfully obtained FDA 510(k) clearance for their Servo-air® Lite ventilator. This achievement has brought great satisfaction to Elin Frostehav, President of Acute Care Therapies at Getinge, who stated, "We are delighted to expand our ventilator product range for the US market. This clearance significantly enhances our ability to serve the non-invasive hospital segment with our advanced ventilation solutions."

The Servo-air® Lite is a turbine-driven ventilator specially designed for non-invasive ventilation. While delivering ICU-level ventilation quality, it is particularly suitable for patients who require additional respiratory support while maintaining spontaneous breathing. Its powerful turbine and durable battery backup enable autonomous operation without reliance on wall gas, making it ideal for intra-hospital transports. The ventilator incorporates embedded workflows, supports High Flow therapy, offers the option for CO2 monitoring, and provides tools to facilitate therapy escalation when necessary.

Customers in the US can expect the availability of Servo-air® Lite from September 2023, enabling healthcare professionals to benefit from a reliable and versatile solution for non-invasive ventilation.


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