Fitbit receives FDA approval for the Fitbit Flow, a low-cost emergency ventilator for use during the COVID-19 pandemic
Fitbit will be able to quickly manufacture large volumes of its new ventilator to assist with the coronavirus crisis and boost the number of ventilators available in the US.
Fitbit, the company known for its fitness wearables, announced on Wednesday that it has received emergency use authorization (EUA) from the US Food & Drug Administration (FDA) for a new emergency ventilator, which Fitbit designed in response to the COVID-19 global health crisis.
An automatic resuscitator, Fitbit Flow was inspired by the MIT E-Vent Design Toolbox, and based on specifications for Rapidly Manufactured Ventilation Systems. Fitbit consulted with clinicians at Oregon Health & Science University and Mass General Brigham Center for COVID Innovation to design the new ventilator. The new emergency ventilator, the Fitbit Flow, will leverage Fitbit’s existing global supply chain so it can scale rapidly if needed.
“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,” said James Park, co-founder and CEO of Fitbit, in a press release. “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 plans to promote collaboration and make its design available through open source software, so people around the world have access to it. It was designed as a low-cost ventilator that will be used only when a traditional commercial ventilator is not available.
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On April 30, the New England Journal of Medicine reported: “U.S. hospitals are already reporting shortages of key equipment needed to care for critically ill patients, including ventilators and personal protective equipment (PPE) for medical staff. Current estimates of the number of ventilators in the United States range from 60,000 to 160,000. No matter which estimate we use, there are not enough ventilators for patients with COVID-19 in the upcoming months.”
The Fitbit Flow builds on standard resuscitator bags, like those used by paramedics. The features support automated compressions and patient monitoring and it was developed to be intuitive and simple to use, to potentially help reduce the strain on the specialized staff who typically operate a commercial ventilator.
“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,” said David Sheridan, MD, MCR, assistant professor of pediatric emergency medicine and co-director of emergency clinical innovation at Oregon Health & Science University.
Fitbit is talking with state and federal agencies about current domestic needs for emergency ventilators and plans to work with US and global aid organizations to handle the ongoing pandemic and any future waves of coronavirus.