Tag: EMERGENCY USE AUTHORIZATION

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 […]

nhalebi-level positive air pressure device
PAP Therapy & Ventilation Systems Product/Vendor Updates

Low-Cost, US Made Bi-Level Machine for Non-Invasive Respiratory Support During COVID-19 Pandemic

Nanotronics announced that it has developed and designed nHale™, a bi-level positive air pressure device to support spontaneously breathing adults weighing over 30 kg. The device has obtained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) to assist patients suffering from COVID-19 disease in traditional healthcare facilities […]