TELFORD, PA — Draeger, Inc. has received U.S. Food and Drug Administration clearance for new software enhancements to its Evita V800 ventilator, adding features designed to support the treatment of patients with acute respiratory distress syndrome and other serious pulmonary diseases.
The FDA’s 510(k) clearance covers the company’s 3.10 software release, which introduces new ventilation tools intended to help clinicians optimize mechanical ventilation and reduce the risk of lung injury associated with prolonged respiratory support.
The enhancements include decelerating flow during volume control ventilation, allowing clinicians to better align airflow with patient demand while adhering to established ARDS treatment protocols.
The software also incorporates guidance maps for positive end-expiratory pressure and fraction of inspired oxygen settings, tools intended to assist clinicians in determining appropriate ventilation parameters for critically ill patients.
Additional features include calculations of driving pressure and semi-automated static compliance measurements, which can aid in managing inspiratory settings and potentially reduce the risk of ventilator-induced lung injury.
The clearance expands the capabilities of the Evita V800, one of Dräger’s flagship intensive care ventilators, at a time when hospitals and healthcare systems continue to invest in critical-care technologies following heightened demand for advanced respiratory equipment in recent years.
“Dräger continues to be on the forefront of technology,” Lothar Thielen, president and chief executive officer of Draeger, Inc., stated. “The addition of these new features for the Evita V800 is another example of Dräger’s commitment to research and development for respiratory care.”
Draeger, headquartered in Telford, serves as the U.S. operations center for Germany-based Dräger, a manufacturer of medical and safety technologies with a global presence in critical care, anesthesia and respiratory support markets.
Financial terms related to the software release were not disclosed.
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