Draeger Receives FDA 510(k) Clearance for Evita V800 Software 3.10 with Advanced ARDS Ventilation Features
核心洞察
Draeger, Inc. (搜索) has received FDA 510(k) clearance for its Evita V800 (搜索) ventilator software version 3.10, announced on June 22, 2026.
The new software introduces decelerating flow during volume control ventilation with ARDSnet safeguards to better match patient demand.
Guidance maps for low and high PEEP-FiO2 tables are included to support clinician decision-making for optimal PEEP and FiO2 settings.
Draeger, Inc. (搜索), the US headquarters of Dräger, announced on June 22, 2026 that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its latest software advancements for the Evita V800 (搜索) ventilator. The 3.10 software release introduces a suite of features designed to enhance mechanical ventilation for patients suffering from pulmonary diseases such as acute respiratory distress syndrome (ARDS (搜索)).
Lothar Thielen, President & CEO for Draeger, Inc. (搜索), stated, "Dräger continues to be on the forefront of technology, the addition of these new features for the Evita V800 (搜索) 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."
Decelerating Flow and ARDSnet Safeguards
A key enhancement in the 3.10 software is the introduction of decelerating flow during volume control ventilation. This feature provides clinician-controlled flow designed to match patient demand while incorporating recommended ARDSnet safeguards. By allowing the flow to decelerate in a controlled manner, the ventilator can better synchronize with the patient's inspiratory effort, potentially improving comfort and gas exchange in critically ill patients.
PEEP-FiO2 Guidance Maps
The updated software includes guidance maps for both low and high PEEP-FiO2 tables. These maps are intended to facilitate clinician decision-making when determining the optimal positive end-expiratory pressure (PEEP) and fraction of inspired oxygen (FiO2) settings. By integrating these evidence-based tables directly into the ventilator interface, clinicians can more readily apply lung-protective ventilation strategies at the bedside.
Driving Pressure and Static Compliance Monitoring
The 3.10 release also adds calculation of driving pressure and semi-automated static compliance measurements. These metrics assist clinicians in managing inspiratory settings and can potentially reduce the risk of ventilator-induced lung injury (搜索) (VILI). Driving pressure, the difference between plateau pressure and PEEP, has emerged as a critical parameter in ARDS (搜索) management, with lower driving pressures associated with improved survival. The semi-automated static compliance feature streamlines what has traditionally been a manual bedside calculation, supporting more consistent and frequent monitoring.
Company Background
Dräger is an international leader in medical and safety technology, with a particular prominence in mechanical ventilation. Founded in 1889, the Dräger Group generated revenues of approximately €3.5 billion in 2025 and maintains a presence in over 190 countries with more than 16,000 employees worldwide. The Evita V800 (搜索) ventilator represents one of the company's flagship intensive care ventilation platforms, and the 3.10 software clearance underscores Dräger's ongoing investment in respiratory care innovation.