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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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FREMONT, Calif., Dec. 16, 2020 /PRNewswire/ Today, Evolve Manufacturing Technologies - a leading Bay-Area contract manufacturer - announces a partnership with biotech company Nanōmix to produce rapid antibody and antigen test kits in the fight against COVID-19. Months into the pandemic, long lines for testing as well as delays in getting results have hampered U.S. efforts to get the coronavirus under control. Now, this hand-held testing device will bring state-of-the-art technology from large laboratories into the palm of the hand.
Evolve Manufacturing Technologies is producing a device that reads and delivers coronavirus diagnostics in just 10 minutes at the very same place where people submit their samples.