April 20, 2020

New Low-Cost Ventilator Approved by FDA for Emergency Use

The Food & Drug Administration (FDA) has authorized the manufacture of a new, low-cost ventilator for emergency use. The Coventor is a compact cereal box-sized ventilator that will be sold by Boston Scientific Corporation for less than $1,000 compared to the $20,000 to $25,000 cost of a traditional ventilator. Boston Scientific plans to begin with a limited run of products and scale up according to demand as the coronavirus outbreak continues to develop, according to the MassDevice article.The medical device maker’s partner, the University of Minnesota, considers Coventor to be a low-cost back-up alternative for doctors.

The Coventor received an Emergency Use Authorization (EUA) from the FDA, which is a temporary designation to help make new, innovative equipment available when traditional equipment is in short supply. Currently, the COVID-19 pandemic is creating a surge of coronavirus-positive patients who often exhibit severe respiratory illness. In extreme cases, these patients require intubation and mechanical ventilation for breathing support as a life-saving measure.

“This allows patients who wouldn’t otherwise have the opportunity to survive, to survive,” Stephen Richardson, one of the device’s developers and a cardiac anesthesiology fellow at the University of Minnesota’s medical school, M Health Fairview, said in a news article posted to the university’s website. “The Coventor gives people a chance and that is what this is all about. Making the ventilator as fast as possible, pushing it to people everywhere.”

Brett Warner of Innovative Health Strategies™ contributed to this alert.

 

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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