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Medical Devices / Submissions and Approvals

FDA Clears Getinge’s Life Support Device Upgrade

April 15, 2019
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Getinge’s software upgrade for its Servo-u and Servo-n ventilator platform has been handed 510(k) clearance by the FDA.

The ventilator platform serves as a life support device for patients suffering from severe respiratory diseases, giving them protective ventilation.

The upgrade adds new features to the device, including volume control with decelerating flow, better alarm management, a smoother setup for ventilation modes and context-based guidance.

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