Draeger, Inc. Announces FDA Clearance for Evita V800 Software 3.10 - Advancing Ventilation Technology

Draeger, Inc., the U.S. headquarters of Dräger, an international leader in medical technology and mechanical ventilation, has received 510(k) clearance from the FDA for the Evita V800 ventilator. This clearance follows the release of the 3.10 software update, which adds features designed to enhance mechanical ventilation for patients with pulmonary diseases such as ARDS.

The new capabilities of the Evita V800 include decelerating flow during volume control ventilation, allowing for clinician-controlled flow that aligns with patient demand while incorporating recommended ARDSnet safeguards. Additionally, the device offers guidance maps for low and high PEEP-FiO2 settings, aiding clinicians in making informed decisions about the best PEEP and FiO2 configurations.

Furthermore, the V800 now calculates driving pressure and provides semi-automated static compliance metrics, assisting healthcare providers in managing inspiratory settings and potentially decreasing the risk of ventilator-induced lung injury (VILI).

Lothar Thielen, President & CEO of Draeger, Inc., commented on the advancements, noting that "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."

For more information about the Evita V800 ventilator, Dräger's products, or to contact local sales representatives, interested parties can visit the company’s website at www.draeger.com or reach out directly via their provided customer service numbers.

Founded in 1889, Dräger generated revenues of approximately €3.5 billion in 2025 and operates in over 190 countries, employing more than 16,000 individuals worldwide.