U.S. Food and Drug Administration (FDA): Respiratory Assist Devices EUAs

Patients requiring breathing support, carbon dioxide removal, or rehabilitation to avoid abdominal wall muscle atrophy caused by lack of use can benefit from respiratory assist devices. The FDA has authorized EUAs to help expand the accessibility of mechanical assist devices, which are critical in treating COVID-19 patients. Breathing apparatuses, ventilator attachments, and other respiratory aid equipment can be classified. The COVID-19 airway management isolation chamber, a respiratory muscle stimulator, and a diaphragmatic pacing therapy system are among the others (CAMIC). During the crisis, well over 50 companies, including BioMedInnovations, LLC, Nanotronics Imaging, Inc, Guangzhou Hypnus Healthcare Co., Ltd, CMI Health, Lanick Med Systems LLC, AutoMedX, Inc., got EUA certification for their ventilation systems. This public health crisis could be a crucial time for industry leaders, particularly those that make respiratory devices. During the epidemic, businesses have a unique opportunity to demonstrate the effectiveness and efficacy of their products. During this situation, new enterprises have a huge chance to introduce goods and demonstrate their efficacy in order to speed up regulatory clearance procedures and win market share.

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