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

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      Respironics’ compact, 31-pound EverFlo Q is the first ultra-quiet concentrator available at an affordable price. It has the ease of use of our popular EverFlo oxygen concentrator and adds an …

      Published Jan 10, 2022 Respiratory Assist Devices EUAs

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      Published Dec 23, 2021 Respiratory Assist Devices EUAs

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      Published Dec 23, 2021 Respiratory Assist Devices EUAs

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      Published Dec 24, 2021 Respiratory Assist Devices EUAs

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      Published Dec 23, 2021 Respiratory Assist Devices EUAs

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      Published Dec 23, 2021 Respiratory Assist Devices EUAs

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    • OxyGo

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      OxyGo products are portable oxygen concentrators (POCs) designed to keep oxygen patients, like you, going without the need of heavy tanks. An OxyGo POC is a lightweight medical device that can make …

      Published Dec 22, 2021 Respiratory Assist Devices EUAs

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