The US Food and Drug Administration has granted 510(k) clearance to Getinge’s Servo-air Lite, a wall gas independent noninvasive mechanical ventilator.
“We are happy to broaden our ventilator product offering for the US market,” says Elin Frostehav, president of acute care therapies at Gothenburg, Sweden-based Getinge, in a release. “This significantly increases our addressable ventilation market in the US by now being able to target the noninvasive hospital segment with our ventilation offering.”
Servo-air Lite is Getinge’s turbine-driven ventilator for noninvasive ventilation. Like all Servo ventilators, it offers intensive care unit-quality ventilation but is more geared toward 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, according to a release from the comapny.
It features embedded workflows, support for high-flow therapy, a carbon dioxide monitoring option, and tools to support escalation of therapy if needed.
The product is expected to be available for customers in the US beginning in September 2023.
Getinge launched its Servo-air ventilator in 2020 as its newest critical care ventilator intended for adult and pediatric patients in the US. According to a release from the company at the time, the COVID-19 health crisis underscored the need for personalized ventilation for critically ill patients.