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Draeger Secures FDA Clearance for Evita V800 Ventilation Software

Draeger Secures FDA Clearance for Evita V800 Ventilation Software

Clinicians treating patients with pulmonary conditions like ARDS now have an upgraded toolkit, as Draeger, Inc. received FDA 510(k) clearance for its Evita V800 software release 3.10. The update introduces precise respiratory control features designed to improve patient outcomes and mitigate the risks associated with mechanical ventilation.

The 3.10 software release brings significant technical refinements to the V800 platform. Among the key additions is a decelerating flow function during volume control ventilation, which allows clinicians to synchronize flow with patient demand while adhering to ARDSnet safety protocols. To support complex decision-making, the system now includes guidance maps for PEEP-FiO2 tables, helping staff navigate optimal settings for oxygenation and pressure.

Beyond flow control, the update automates critical calculations for driving pressure and static compliance. By providing these metrics, the system assists in managing inspiratory settings, a move aimed at reducing the incidence of ventilator-induced lung injury (VILI). Lothar Thielen, President and CEO of Draeger, Inc., stated that these features underscore the company’s ongoing investment in respiratory care research and development. The deployment of this software marks a shift toward more semi-automated support in acute care environments, aiming to streamline clinical workflows while maintaining rigorous safety standards.

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