Therapy Areas: Respiratory
Getinge granted FDA market clearance for software upgrade of Servo-u and Servo-n ventilator platform
11 April 2019 -

Intensive-care company Getinge reported on Wednesday the receipt of US Food & Drug Administration's (FDA) 510(k) market clearance for a new software version of the Servo-u and Servo-n mechanical ventilator platform in aid of patients with severe respiratory diseases.

According to the World Health Organisation, respiratory diseases make up five of the 30 most common causes of death. Lung diseases and ARDS (Acute Respiratory Distress Syndrome) play a significant role. Virtually all patients with ARDS require mechanical ventilation to assist the lungs with oxygenation and provide time to heal.

The company's upgraded software includes Servo Compass and High Flow therapy as well as additional advancements for ventilation therapy compliant with the ARDSnet protocol 3 and goal directed lung protective ventilation for all patient categories with the inclusion of measurement of driving pressure. The new features include volume control with decelerating flow, enhanced alarm management, streamlined setup for modes of ventilation and context based guidance for ease of use.

Getinge expects the new software and related modules to be launched in the US at the end of April 2019.

Servo Compass visualises volume and pressure in relation to set targets in invasive modes, alerting clinicians to potentially changing conditions and allowing them to intervene with appropriate therapy. High Flow therapy reduces the patient's work of breathing, improving comfort and tolerance. The goal is to enable clinicians to wean patients from the ventilator and promote lung protective ventilation.

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