Summary: CorVent Medical’s Respond ventilator, designed for pediatric to adult patients, has received FDA 510(k) clearance as the first U.S.-manufactured ventilator cleared in over 20 years.
Key Takeaways:
- It offers affordability and reliability with features like non-invasive capabilities, hot-swappable batteries, and EMR integration.
- CorVent Medical aims to expand its product line with value-based medical device solutions.
CorVent Medical, a manufacturer of medical devices and mechanical ventilators, announced that its Respond ventilator has received U.S. FDA 510(k) clearance.
Lightweight Ventilator
The Respond ventilator combines traditional mechanical ventilation features with durable, low-maintenance components, reducing service and maintenance needs. Using non-proprietary circuits and low-pressure oxygen, it is designed for long-term affordability.
“Simple and highly reliable, the Respond ventilator is a front-line ventilator in a value-focused and resource-constrained world,” said Patrick Troy, MD, chief medical officer, CorVent Medical.
Features and Applications
The Respond ventilator supports pediatric to adult patients with standard breathing modes and both invasive and non-invasive capabilities. Additional features include:
- Patient-prioritized alarm system
- Hot-swappable batteries
- EMR integration for critical data access
“This marks a significant milestone as it is the first U.S.-manufactured ventilator to receive FDA clearance in over 20 years,” says Richard S. Walsh, president and CEO of CorVent Medical. He added that this achievement demonstrates CorVent’s dedication to innovation and value-based solutions for healthcare systems.
Pandemic Reliability
During the pandemic, CorVent’s Respond-19 ventilator shipped worldwide under CE Mark and EUA authorization, proving its reliability with millions of service hours globally.
