Sleep Disorders

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 […]

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PAP Therapy & Ventilation Systems

Dräger Extends Ventilation Solutions Into U.S. Long-Term Care Facilities Through Breas Medical Distribution Agreement

Dräger announced that it has entered into an agreement with Breas Medical, a global medical device company delivering respiratory care solutions throughout the continuum of care. Together, they will provide long-term acute care (LTAC) and skilled nursing facilities (SNF) in the U.S. access to both Dräger and Breas Medical mechanical […]

breathdirect bdr 19
PAP Therapy & Ventilation Systems

BreathDirect Passes UL Independent Testing for Low-Cost, U.S. Built BDR-19 Ventilator

California-based medical device company BreathDirectTM, developers of an affordable, full-service ventilator designed in response to COVID-19, announced that Underwriters Laboratory, the world’s largest independent testing organization, has completed testing of the BDR-19©, evaluating its safety and performance to treat ventilatory insufficiency. UL determined that the BDR-19© meets the criteria established in the […]