CorVent Gets FDA OK for Respond Critical Care Ventilator

CorVent Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Respond ventilator.

The company said the Respond ventilator is cost-effective and designed to delivery safe, simple, and smart ventilation as well as expand access to quality care.

According to CorVent, the system is lightweight and easy to use. It combines elements of traditional mechanical ventilation with durable, long-lasting components, removing the need for service and maintenance contracts.

The full-featured ventilator uses non-proprietary circuits and accessories along with low-pressure oxygen. It includes all of the standard breathing modes, with both invasive and non-invasive ventilation settings.

Other features include a patient-prioritized alarm system, hot swappable batteries, and communication for electronic medical record (EMR) integration.

“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 at CorVent Medical. “Its robust design maximizes total cost of ownership, delivering significant savings for hospital systems, emergency stockpiles, long-term acute care hospitals (LTACHs) and skilled nursing facilities (SNFs).”

CorVent designed and commercialized the Respond-19 ventilator during the worldwide COVID-19 pandemic and shipped it worldwide under CE mark and emergency use authorization (EUA). It was proven to be safe, effective, and reliable with millions of hours of service around the globe.

“We are extremely pleased that the U.S. FDA has cleared our Respond Critical Care Ventilator. Achieving FDA 510(k) clearance for the RESPOND ventilator is a testament to our commitment to advancing medical technology and addressing the critical needs of patients and healthcare professionals,” said Richard S. Walsh, president and CEO of CorVent Medical. “This accomplishment not only reinforces our dedication to innovation but also marks a significant step in revitalizing U.S. manufacturing in the medical device sector. This marks a significant milestone as it is the first U.S.-manufactured ventilator to receive FDA clearance in over 20 years. We plan on expanding our product line with additional transformational products that deliver value-based solutions for our customers.”