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

Rhea-AI Summary

Draeger (OTC:DGWPF) received FDA 510(k) clearance on June 22, 2026 for Evita V800 software 3.10, enabling US marketing of new ventilation features.

The update adds decelerating flow in volume control, PEEP-FiO2 guidance maps, and driving pressure/static compliance calculations for managing ARDS and reducing ventilator-induced lung injury risk. Draeger reported about €3.5 billion revenue in 2025.

Positive

• FDA 510(k) clearance for Evita V800 software 3.10 in the US market
• New decelerating flow option during volume control to match patient demand with ARDSnet safeguards
• Guidance maps for low and high PEEP-FiO2 tables to support clinician decision making
• Driving pressure calculation and semi-automated static compliance to manage inspiratory settings and VILI risk
• Dräger Group 2025 revenue of around €3.5 billion, present in over 190 countries

Negative

• None.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

TELFORD, Pa.  , June 22, 2026 /PRNewswire/ -- Draeger, Inc., US headquarters of Dräger, an international leader in the field of medical technology and a worldwide leader in mechanical ventilation, announced today that it has received 510(k) clearance from the FDA to market its latest advancements for the Evita V800 ventilator.

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.

• 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 Fi02 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.

For more information, visit the website at www.draeger.com or contact your local Dräger sales representative at 1-800-4DRAGER.

You can find more information and pictures in our press center:
https://www.draeger.com/en-us_us/Newsroom/Press-Center

Dräger is an international leader in the fields of medical and safety technology. Our products protect, support, and save lives. Founded in 1889, Dräger generated revenues of around € 3,5 billion in 2025. The Dräger Group is currently present in over 190 countries and has more than 16,000 employees worldwide. Please visit http://www.draeger.com for more information.

Contact
Communications: presse@draeger.com
Press Contact North America: Laura Edwards, Tel. +1 215 565-5868, laura.edwards@draeger.com
Investor Relations: Thomas Fischler, Tel. +49 451 882-2685, thomas.fischler@draeger.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/draeger-inc-announces-fda-clearance-for-evita-v800-software-3-10--advancing-ventilation-technology-302806714.html

SOURCE Draeger

FAQ

What did Draeger (DGWPF) announce about FDA clearance for Evita V800 on June 22, 2026?

Draeger announced FDA 510(k) clearance for Evita V800 software 3.10, allowing US marketing of new ventilation features. According to Draeger, the upgrade enhances ventilation support for patients with pulmonary disease, including ARDS, through added tools for safer and more controlled mechanical ventilation.

What new clinical features are included in Draeger’s Evita V800 software 3.10 for ARDS patients?

Evita V800 software 3.10 adds decelerating flow, PEEP-FiO2 guidance maps, and driving pressure calculations. According to Draeger, these features help clinicians match flow to patient demand, choose PEEP-FiO2 settings, and adjust inspiratory parameters to potentially lower ventilator-induced lung injury risk.

How does FDA-cleared Evita V800 software 3.10 improve PEEP-FiO2 management according to Draeger?

Evita V800 software 3.10 introduces guidance maps for low and high PEEP-FiO2 tables. According to Draeger, these maps support clinicians in selecting best PEEP and FiO2 combinations, aiming to standardize ARDSnet-style strategies and simplify complex ventilation decisions at the bedside.

What is the significance of driving pressure and static compliance features in Evita V800 software 3.10?

The software calculates driving pressure and offers semi-automated static compliance for inspiratory management. According to Draeger, these metrics assist clinicians in refining ventilator settings, which can potentially reduce the risk of ventilator-induced lung injury in vulnerable pulmonary patients.

How large is Draeger’s global business and where does Draeger (DGWPF) operate?

Draeger reported around €3.5 billion in revenue for 2025 and operates in over 190 countries. According to Draeger, the Group employs more than 16,000 people worldwide and focuses on medical and safety technology products that protect, support, and save lives.