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 […]
Tag: EMERGENCY USE AUTHORIZATION
ATS Statement on Convalescent Plasma and Testing of Asymptomatic COVID-19 Patients
The American Thoracic Society is alarmed by two federal agency policy actions that may significantly impact our nation’s COVID-19 response. This week, the FDA issued an emergency use authorization (EUA) for the use of convalescent plasma to treat COVID-19 disease. This action was taken despite a lack of adequate evidence demonstrating a clear benefit […]
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 […]






