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Fitbit’s Flow ventilator receives FDA emergency approval

Published on 04/06/20 at 11:16am
Photo by Raysonho @ Open Grid Scheduler / Grid Engine

The FDA has granted emergency approval for Fitbit’s ‘Fitbit Flow’ ventilator, a low cost piece of equipment to help fight the COVID-19 pandemic.

Fitbit Flow was inspired by MIT’s E-Vent Design Toolbox and based on the specifics for the Rapidly Manufactured Ventilation Systems. It was designed in collaboration with clinicians at the Oregon Health and Science University and Mass General Brigham Center for COVID Innovation.

The product was designed as a low-cost ventilator that can be used when a traditional commercial ventilator is not available. The Flow uses standard resuscitator bags and supports automated compressions and patient monitoring. It was designed to be simple to use to reduce the need for specialised staff to operate it.

James Park, the CEO and founder of Fitbit, said in a press release that: “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 health care systems caring for them. We saw an opportunity to rally our expertise in advanced sensor development, manufacturing, and our global supply chain to address the critical and ongoing need for ventilators and help make a difference in the global fight against this virus.”

Fitbit will use its existing supply chain to rapidly increase production if needed. The company also plans to make the design available through open source software so people around the world can access it.

Dr David Sheridan, assistant professor of paediatric emergency medicine and co-director of emergency clinical innovation at Oregon Health & Science University, said: “Fitbit Flow is a great example of the incredible innovation that emerges 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. 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.”

Conor Kavanagh

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