Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its […]

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

The software upgrades for Servo-u and Servo-n include the automatic stepwise recruitment maneuver, a standardized and automated workflow designed to guide lung recruitment and help clinicians identify a personalized PEEP that provides the lowest driving pressure.

Additionally, the upgrades offer stress index and transpulmonary pressure monitoring, including key parameters for the assessment of lung stress during controlled and spontaneous ventilation, which compliments the lung-protective toolkit that divides the cognitive workflow between the clinician and the ventilator.

Getinge’s clearance also includes the Heliox helium and oxygen combination therapy that facilitates laminar flow and minimizes airway pressure to help reduce the work of breathing in those suffering from obstructive lung diseases.

The Servo-u MR system expands Getinge’s ventilator portfolio to reach the MRI room. The system guides the ventilator into a safe position and includes a magnetic field indicator with visual and audible alerts, plus an auto-lock handle that locks all four wheels as soon as the clinician releases the ventilator.

“The COVID-19 pandemic and the heightened awareness of respiratory health has driven the need for personalized ventilation solutions for critically ill patients,” Getinge North America president Eric Honroth said in the release. “Now more than ever, options for personalized lung protection and personalized weaning solutions are at the forefront of respiratory patient health. Getinge strives to support clinicians and patients by optimizing lung protection and delivering solutions for personalized ventilation.”

Original Article: (