Nectar Product Development and its affiliated medical device organization, BreathDirectTM (FDA), announced that its BDR-19TM ventilator had received Emergency Use Authorization from FDA.
FREMONT, CA: The top medical design firm, Nectar Product Development, and its affiliated medical device organization, BreathDirectTM, recently announced that its BDR-19TM ventilator had secured Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
FDA regulators approved the BDR-19TM to treat patients with ventilatory insufficiency after conducting a comprehensive review process to evaluate its safety and performance. New learnings and evolved treatment guidelines for ventilation support of COVID-19 patients and others are incorporated into the design and safety features. In the United States, the BDR-19TM is now approved for immediate medical use.
"We designed the BDR-19TM as a continuous use, critical-care ventilator, built primarily for intensive care units and capable of a full continuum of respiratory support," said BreathDirectTMFounder and CEO Darren Saravis. "We have been in productive dialogue with the FDA as new protocols for care of COVID-19 patients have evolved. The result of our ongoing engineering enhancements is a safe, durable, easy-to-use machine that incorporates the learnings from respiratory therapists and E.R. physicians over this long pandemic year."
The FDA's Emergency Use Authorization of the BDR-19TM comes at a crucial time as governments, hospitals, and medical centers reconsider ventilator inventories. It is due to the concerns that several stockpiled ventilators do not meet the minimum criteria for treating Acute Respiratory Distress Syndrome (ARDS), with just 10 percent of them are appropriate for exclusive ICU critical care use. The BDR-19TM provides a cost-effective alternative for organizations that must plan and prepare for an unpredictable future, with cases still rising in some areas and the possibility of renewed surges.
"Looking ahead," says Saravis, "we expect to see a steady demand for more capable, multi-functional ventilators from hospitals in the U.S. and abroad -- including those in developing countries. California is at the ready, with affordable, U.S.-built, life-saving equipment that will ensure medical readiness for any contingency. All components of the BDR-19TM are sourced in the U.S., resulting in a secure and stable supply chain.Our manufacturing partners at Evolve Manufacturing in Fremont, California have designed and readied their assembly lines so that we can have ventilators ready to ship to medical facilities within weeks."