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

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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.


Investor Relations:
Lars Mattsson, Head of Investor Relations
Phone: +46 (0)10 335 0043
Email:
lars.mattsson@getinge.com

Media contact:
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
Email:
anna.appelqvist@getinge.com

About Getinge

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.

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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.
Elin Frostehav, President Acute Care Therapies at Getinge