FDA authorizes production of a new ventilator that costs up to 25x less than existing devices

The U.S. Food and Drug Administration (FDA) has authorized the manufacture of the Coventor ventilator, a new hardware design first developed by the University of Minnesota. The project sought to create a ventilator that could provide the same level of life-saving care as existing ventilator models, but with a much lower cost to help ramp production quickly and make them affordable to the health institutions that need them.

The Coventor becomes the first of these types of novel ventilator designs to earn an Emergency Use Authorization (EUA) from the FDA. Just like it sounds, an EUA isn’t a full traditional medical device approval like the drug and device regulator would ordinarily issue, but an emergency, temporary grant in the interest of helping provide access to resources in short supply, or without the usual full chain of approvals, in times of crisis.

The coronavirus pandemic is potentially the best example of such a crisis in modern memory, and the respiratory illness caused by COVID-19 requires treatment including intubation and ventilator breathing su ..

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