Getinge receives US FDA 510(k) clearance for Servo-air® Lite

Getinge announces clearance from the US FDA for Servo-air® Lite, a wall gas independent non-invasive mechanical ventilator.

“We are happy to broaden our ventilator product offering for the US market”, says Elin Frostehav, President Acute Care Therapies at Getinge. “This significantly increases our addressable ventilation market in the US, by now being able to target the non-invasive hospital segment with our ventilation offering.” 

Servo-air® Lite is Getinge’s turbine-driven ventilator for non-invasive ventilation. Like all Servo ventilators, it offers ICU-quality ventilation but is more geared towards spontaneously breathing patients in need of extra breathing support. With its powerful turbine and long-lasting battery backup power, it can also be operated independent of wall gas and is suitable for intrahospital transports. It features embedded workflows, support for High Flow therapy, CO₂ monitoring option and tools to support escalation of therapy if needed to.

The product is expected to be available for customers in the US from September 2023.

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