FARGO, N.D., November 19, 2024—CorVent Medical, a medical device and mechanical ventilator manufacturer, announced that its RESPOND ventilator has received U.S. FDA 510(k) clearance. The RESPOND Ventilator is cost-effective and designed to deliver simple, safe and smart ventilation, expanding access to quality care for healthcare systems, providers and patients.
The RESPOND comes with a 5-year Limited Warranty, an industry first, making the total cost of ownership the purchase price. The system is a lightweight and easy-to-use ventilator that combines proven elements of traditional mechanical ventilation with durable, long-lasting components, eliminating 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,” said Patrick Troy, MD., chief medical officer, 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).”
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.
“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, 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.”
During the worldwide pandemic, CorVent Medical designed and commercialized the Respond-19 ventilator which shipped worldwide under CE Mark and EUA authorization. The Respond-19 ventilator has proven to be safe, effective and reliable, having amassed millions of hours in service around the world.
About CorVent Medical
Founded in 2020, CorVent Medical Inc. is the only U.S.-owned and operated respiratory and ventilation designer and manufacturer dedicated to creating value based respiratory and ventilation solutions for healthcare systems, providers and patients. Headquartered in Fargo, North Dakota, CorVent is committed to delivering dependable, easy-to-use technologies for both routine, stockpile and emergency ventilation, enabling providers to focus on what matters most: patient care.
Contact
Kevin Plihal, Vice President of Marketing
Email: kplihal@corventmedical.com
