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FDA Allowing Modifications To Ventilator Equipment To Bolster Supplies During COVID-19 Crisis

 
• By Sue Darcey

The US agency says it will not object to medtech manufacturers making minor modifications to the motors, tubing or software of medical ventilators – or even to pressing CPAP (continuous positive airway pressure) equipment into service to use as ventilators – during the COVID-19 public health emergency.

patient with mask ventilation in operation room

The US Food and Drug Administration says in a new immediately-in-effect guidance that it will temporarily allow limited modifications of medical-use ventilation equipment during the coronavirus public health emergency to bolster supplies of ventilators to treat patients during the coronavirus pandemic.

The FDA also would allow use of anesthesia gas machines, and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), to treat COVID-19 patients with respiratory insufficiency, it...

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• By Marion Webb

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Recall Alerts For Boston Scientific, Philips, J&J, And More

 
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• By Shubham Singh

Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.