CorVent Medical’s Respond ventilator, offering both invasive and non-invasive capabilities, has received FDA 510(k) clearance.
RT’s Three Key Takeaways:
- FDA Clearance: CorVent Medical’s Respond ventilator has received FDA 510(k) clearance.
- Designed for Versatility: The ventilator supports both invasive and non-invasive breathing modes for pediatric through adult patients, with features such as hot-swappable batteries and EMR integration.
- Focus on Affordability and Longevity: Respond uses non-proprietary components and low-pressure oxygen to prioritize long-term affordability and eliminate the need for service contracts.
North Dakota-based CorVent Medical, a medical device and mechanical ventilator manufacturer, announced that its Respond ventilator has received US Food and Drug Administration (FDA) 510(k) clearance.
The Respond ventilator is described by the company as cost-effective, lightweight, easy to use, and designed to deliver “simple, safe, and smart ventilation.” Respond comes with a five-year limited warranty and combines elements of traditional mechanical ventilation with long-lasting components to eliminate the need for service and maintenance contracts.
The Respond ventilator is a full-featured ventilator, which uses non-proprietary circuits and accessories along with low-pressure oxygen for long-term affordability.
“Simple and highly reliable, the Respond ventilator is a front-line ventilator in a value-focused and resource-constrained world,” says Patrick Troy, MD, chief medical officer at CorVent Medical, in a release. “Its robust design maximizes total cost of ownership, delivering significant savings for hospital systems, emergency stockpiles, long-term acute care hospitals, and skilled nursing facilities.”
Respond Ventilator Features
Engineered to meet the needs of pediatric through adult patients, the Respond ventilator includes all of the standard breathing modes, with both invasive and non-invasive ventilation capabilities. Additional features include a patient-prioritized alarm system, hot swappable batteries, and communication for EMR integration, supporting seamless access to critical patient data.
“This accomplishment not only reinforces our dedication to innovation but also marks a significant step in revitalizing US manufacturing in the medical device sector. This marks a significant milestone as it is the first US-manufactured ventilator to receive FDA clearance in over 20 years,” says Richard S. Walsh, president and CEO, CorVent Medical, in a release. “We plan on expanding our product line with additional transformational products that deliver value-based solutions for our customers.”
During the COVID-19 pandemic, CorVent Medical designed and commercialized the Respond-19 ventilator which shipped worldwide under CE Mark and EUA authorization.
Photo caption: Respond ventilator
Photo credit: CorVent Medical
