Fitbit gains FDA authorization for its low-cost emergency ventilator

Fitbit gains FDA authorization for its low-cost emergency ventilator

Fitbit has secured an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Fitbit Flow emergency ventilator. The ventilator {hardware} is low-cost, and doesn’t require very a lot coaching or experience to make use of, making it a great resolution for deployment in situations the place healthcare programs are overwhelmed by useful resource pressure stemming from the COVID-19 pandemic.

The Fitbit ventilator is predicated on the MIT E-Vent system, in addition to specs offered by the UK authorities for ventilators for use by hospitals in that nation in the course of the ongoing coronavirus outbreak. I’s an automatic resuscitator-style ventilator, which primarily replicates the operate of the sorts of handbook resuscitation baggage utilized by paramedics and EMTs within the discipline.

This is a method of emergency ventilator that has grow to be common in mild of the pandemic, partly as a result of they are often constructed utilizing comparatively inexpensive and available parts vs. the usual fashion of medical ventilators healthcare services usually use. Fitbit says it believes that its design is especially efficient, with the appropriate mixture of sensors, automated alarms and different affected person monitoring options that complement the automation of resuscitation bag pump.

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While loads of the eye across the want for emergency use ventilators has subsided in latest weeks, the necessity nonetheless exists, and can probably resurge together with new waves of COVID-19 transmission within the coming months. Projects just like the Fitbit Flow purpose to supply choices ought to they be required, and the FDA EUA signifies that the corporate can now work with its present manufacturing companions to construct these in giant volumes to handle want.

Ventilators just like the Flow aren’t designed to exchange present, conventional medical ventilators – as an alternative, they’re meant as stopgaps, for use solely when that {hardware} isn’t obtainable in portions wanted to deal with sufferers.


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