CorVent Medical announced it received FDA 510(k) clearance for its Respond critical care ventilator system.
The company designed Respond as a cost-effective option to deliver simple, safe and smart ventilation. It aims to expand access to quality care for healthcare systems, providers and patients.
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Respond, a lightweight, easy-to-use ventilator, combines elements of traditional mechanical ventilation with durable, long-lasting components. It eliminates the need for service and maintenance contracts and, as a full-featured ventilator, 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 Dr. Patrick Troy, 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).”
CorVent said it engineered Respond to meet the needs of all patients, from pediatric to adult. It includes all standard breathing modes, with both invasive and non-invasive ventilation capabilities. It also features a patient-prioritized alarm system, hot, swappable batteries and communication for EMR integration.
“We are extremely pleased that the U.S. FDA has cleared our Respond critical care ventilator,” said President and CEO Richard S. Walsh.” 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. 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.”
