Fitbit receives FDA approval for Fitbit Flow
The device has obtained Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for use during the Covid-19 pandemic.
The device consists of sensors and alarms to monitor patients and is designed with ease of use in mind to avoid adding additional stress to healthcare workers during this difficult time.
Fibit Flow received EUA on 1st June 2020, and according to the FDA’s official document, the device is “indicated for the continuous mechanical ventilatory support of adult patients.” The FDA describes the device as an “accessory to a manual resuscitator” which is “intended for use by qualified, trained personnel under the direction of a physician only when an FDA-cleared clinical ventilator is not available during the Covid-19 pandemic.”
Fitbit aims to produce large volumes of these devices within a short time frame, as a result of the organisation’s vast infrastructure and manufacturing capabilities which were already in place prior to the pandemic.
David Sheridan, assistant professor of peadiatric emergency medicine and co-director of emergency clinical innovation at Oregon Health and 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.”
James Park, co-founder and CEO of Fitbit, commented: “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.
“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.”