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BreathDirect’s BDR-19™ Critical Care Ventilator from California’s Nectar Product Development, Receives FDA Emergency Use Authorization
March 10, 2021 GMT
LONG BEACH, Calif., March 10, 2021 /PRNewswire/ Leading medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirect™, today announced that its BDR-19™ ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
Approval of the BDR-19™ for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators to gauge its safety and performance. The resulting design and safety features incorporate new learnings and evolved care protocols for ventilation support of COVID-19 patients and others. The BDR-19™ is now authorized for immediate medical use throughout the U.S. ....

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