FDA Clears Upgraded Software for Evita V800 Ventilator

Draeger Inc has received 510(k) clearance from the USFDA to market its 3.10 software for the Evita V800 ventilator, according to a company news release.

With the clearance of the 3.10 software release, the V800 provides additional features to help enhance mechanical ventilation of patients suffering from pulmonary disease such as ARDS.

New features include:

• Decelerating flow during volume control ventilation provides clinician-controlled flow to match patient demand with recommended ARDSnet safeguards.
• Guidance maps for low and high PEEP-FiO₂ tables to facilitate clinician’s decision making in determining best PEEP and FiO₂ settings.
• Calculation of driving pressure and semi-automated static compliance to assist clinicians in management of inspiratory settings which can potentially reduce the risk of ventilator-induced lung injury (VILI).

“Dräger continues to be on the forefront of technology, the addition of these new features for the Evita V800 is another example of Dräger’s commitment to research and development for respiratory care. Dräger is proud to again serve our customers with the latest technology,” said Lothar Thielen, President & CEO for Draeger, Inc.