FDA issues EUAs for ventilator devices, surgical masks
The Food and Drug Administration Tuesday authorized the emergency use of three types of ventilator accessories for treating COVID-19 patients.
The is a patient interface for helmet-based non-invasive positive pressure ventilation; a from VORTRAN Medical Technology 1 Inc. provides constant-flow pressure-cycled ventilator support; and a device from Nanotronics Imagining Inc. provides bi-level positive air pressure support.
FDA on Wednesday also issued an umbrella emergency use authorization to meet supply demands for certain that meet performance requirements for use in health care settings to provide a physical barrier to fluids and particulate materials to prevent exposure to respiratory droplets and large particles.
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