Getinge receives US FDA 510(k) clearance for three products, expanding the Servo ventilator platform

Rhea-AI Summary

Getinge has secured US FDA clearance for several software updates for its Servo-u and Servo-n ventilators, enhancing functionality across all patient categories. The new features include Automatic Stepwise Recruitment maneuver and Heliox therapy, designed for personalized lung protection. Moreover, the Servo-u MR ventilator has been approved for MRI environments. These advancements, driven by the pandemic's impact on respiratory health, are set to be available to US markets by July 2021. This proactive approach underlines Getinge's commitment to innovation and patient care.

Positive

• FDA clearance for new software options in Servo-u and Servo-n ventilators.
• Introduction of Servo-u MR ventilator designed for MRI use.
• Enhanced functionalities aimed at personalized lung protection across all patient categories.
• Inclusion of Heliox therapy to improve patient care in obstructive lung diseases.

Negative

• None.

GÖTEBORG, Sweden, April 22, 2021 /PRNewswire/ -- Today, Getinge announces clearance from the US FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room.

"The COVID-19 pandemic and the heightened awareness of respiratory health have driven the need for personalized ventilation solutions for critically ill patients. 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," said Eric Honroth, President, Getinge North America.

With this software upgrade for the Servo-u and Servo-n combined, Getinge adds several new functionalities and options across all patient categories – adult, pediatric and neonatal. Getinge broadens its portfolio of lung-protective tools, including Automatic Stepwise Recruitment maneuver (Auto SRM), a standardized and automated workflow that guides lung recruitment and helps clinicians identify a personalized PEEP that provides the lowest driving pressure, which is a variable strongly associated with patient survival in ARDS¹. Stress index and Transpulmonary pressure monitoring, including key parameters for assessment of lung stress during controlled and spontaneous ventilation, complements the lung protective toolkit, which was designed to optimally divide the cognitive workload between the clinician and the ventilator.
Additionally, the clearance includes Heliox therapy. Heliox is a mixture of helium and oxygen that facilitates laminar flow and minimizes airway pressure due to its low density. This helps reduce the work of breathing (WoB) of patients suffering from obstructive lung diseases.

Getinge also received clearance to introduce the Servo-u MR to the US market, a complement to the Servo Family, expanding Getinge's platform of ventilators into the MRI room. Designed to guide the ventilator into a safe position, the Servo-u MR includes a magnetic field indicator with visual and audible alerts and an auto-lock handle that locks all four wheels as soon as the clinician releases the ventilator.

"We are seeing a transformation in the way healthcare providers view respiratory health," said Eric Honroth. "With this clearance, we are excited to be part of driving this transformation, working hand in hand with experts and clinicians."

Getinge remains committed to innovation in ventilation platforms. With its rich legacy of firsts, Getinge is proud to bring innovative products and solutions to clinicians through this most recent 510k clearance.

The new options and the Servo-u MR ventilator are expected to be available in the US in July 2021.

Read more about Getinge's Servo ventilators.

1. Amato M, Meade M, Slutsky A, et al. Driving Pressure and Survival in the Acute Respiratory Distress Syndrome. N Engl J Med. 2015; 372:747–755.

MCV00107385 REVA

Media contact:

Ampy Vasquez
Director, Marketing Communications
(+1) 862-221-4626
Amparo.vasquez@getinge.com

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https://news.cision.com/getinge/r/getinge-receives-us-fda-510-k--clearance-for-three-products--expanding-the-servo-ventilator-platform,c3330644

The following files are available for download:

https://mb.cision.com/Main/942/3330644/1405297.pdf	Getinge receives US FDA 510(k) clearance for three products, expanding the Servo ventilator platform 04 21 2021
https://news.cision.com/getinge/i/getinge-servo-family,c2903172	Getinge Servo Family
https://news.cision.com/getinge/i/eric-honroth--president--getinge-north-america,c2903174	Eric Honroth, President, Getinge North America

 

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SOURCE Getinge

FAQ

What FDA clearances did Getinge receive for GNGBY on April 22, 2021?

Getinge received FDA clearance for new software options for the Servo-u and Servo-n ventilators and the new Servo-u MR ventilator.

When will the new ventilator options be available in the US?

The new options and the Servo-u MR ventilator are expected to be available in the US in July 2021.

What benefits do the new Servo-u and Servo-n ventilator software upgrades provide?

The upgrades include features like Automatic Stepwise Recruitment maneuver and Heliox therapy, improving personalized lung protection for patients.

How do Getinge's new ventilators impact respiratory health?

The new ventilators and software upgrades support clinicians in optimizing lung protection and addressing respiratory health needs during the pandemic.