PVA Becomes First Nonmedical Manufacturer In The World To Get FDA Approval For Its Ventilator Design

A Capital Region company has become the first in the nation (and world!) to win approval from the US Food and Drug Administration (FDA) for a crucial medical device in the fight against the COVID-19 virus. Cohoes-based Precision Valve and Automation (PVA) announced today (April 20) that the FDA had approved the production and use of PREVENT, an emergency ventilator both designed and manufactured at PVA’s Cohoes headquarters. In response to the COVID-19 pandemic and ventilator shortages across the country, especially here in New York State, the FDA issued PREVENT approval under a “fast track” process known as Emergency Use Authorization. Primarily a robotics and tech dispenser developer, PVA is also the first nonmedical device manufacturer in the world to receive FDA approval to make these ventilators under the Emergency Use Authorization.

“In one short month we’ve taken a concept through to FDA approval,” says PVA’s Founder and President Tony Hynes. “To be the only company in New York State to receive authorization and the only alternative company in the world to be recognized by the FDA for ventilator production is something our team can be proud of at PVA. Someone, somewhere may now have a chance to survive COVID-19 because of what we’re doing here in Albany.”

The PREVENT emergency ventilator will be used for adult patients weighing more than 66 pounds and will feature an active alarm system providing immediate feedback to medical workers. Utilizing its 135,000-square-foot facility in Cohoes, PVA plans to start shipping the ventilators by the end of the month, potentially up to 250 of them a day.

PVA has some powerful resources at its disposal. Founded in 1992, the company got its start selling automated and manual dispensing valves (products used in a lot of hardware and circuit board construction), as well as building robots related to dispensing valves out of the Rensselaer Polytechnic Institute’s Incubator Center in Troy. Since then, PVA has grown into an international company—with regional sites in North America, Asia and Europe—building robotics and tech for diverse industries from aerospace and military defense to electronics and renewable energy.

“Governor Cuomo and President Trump have repeatedly called on corporate America to fill the void in manufacturing medical devices,” says Hynes. “Well, here we are.”

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