PAP Therapy & Ventilation Systems

breathdirect bdr 19
PAP Therapy & Ventilation Systems

BreathDirect’s BDR-19 Critical Care Ventilator Receives FDA Emergency Use Authorization

Medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirectTM, announced that its BDR-19TM ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Approval of the BDR-19TM for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators […]

vent splitter
PAP Therapy & Ventilation Systems

FDA Update on Ventilator Splitters

The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. Although the FDA has not received any adverse event […]