Fitbit gets emergency FDA approval for its ventilator

5 Jun 2020

The Fitbit Flow ventilator. Image: Fitbit

Fitbit said that its $5,000 emergency ventilator is designed to be used only when a traditional commercial ventilator is not available.

On Wednesday (3 June), Fitbit announced that its ventilator design, the Fitbit Flow, has been granted emergency use authorisation by the US Food and Drug Administration (FDA).

Fitbit, the wearable tech company that Alphabet announced plans to buy last year for $2.1bn, built the ventilator in response to the Covid-19 pandemic.

According to the company, the automatic resuscitator was inspired by the MIT E-Vent Design Toolbox and is based on specifications for rapidly manufactured ventilation systems. Fitbit told The Verge that it plans to sell the devices for around $5,000 and that production is scheduled to begin this month.

Fitbit said that its goal is to supply its new devices to healthcare systems around the world that do not have a sufficient number of traditional commercial ventilators. The device is designed to be used only when a traditional commercial ventilator is not available.

‘Covid-19 has challenged us to push boundaries’

Fitbit said that during development and testing, the company consulted with Oregon Health and Science University (OHSU) emergency medicine clinicians treating Covid-19 patients.

James Park, CEO and co-founder of Fitbit, said: “Covid-19 has challenged all of us to push the boundaries of innovation and creativity, and use everything at our disposal to more rapidly develop products that support patients and the healthcare systems caring for them.”

Park said the company “saw an opportunity” to use its expertise in advanced sensor development, manufacturing and its global supply chain to address the ongoing need for ventilators.

The medical device builds on standard resuscitator bags, like those used by paramedics, with additional instruments, sensors and alarms that work together to support automated compressions and patient monitoring.

Fitbit said that the Flow device is designed to be “intuitive and simple to use” with the goal of helping to reduce the strain on specialised staff who are typically needed to operate a commercial ventilator.

Dr David Sheridan, assistant professor of paediatric emergency medicine and co-director of emergency clinical innovation at OHSU, said the Fitbit Flow represents a “great example” of what can emerge when academia and industry employ problem-based innovation to respond quickly to an important need.

“Covid-19 is a new illness and we still have much to learn about the progression, treatment and potential recurrence of this disease,” Sheridan said. “It’s critical that we develop solutions that can help ensure our health systems have the equipment they need now, and in the future if we do see a resurgence of Covid-19.”

Kelly Earley was a journalist with Silicon Republic