Fitbit ventilator approved by FDA for emergency Covid-19 use
Image credit: Fitbit
The Fitbit Flow – a basic ventilator developed by the wearable technology company – has been approved for emergency use by the Food and Drug Administration (FDA), meaning that it can be used to treat patients during the coronavirus pandemic.
The FDA's 'Emergency Use Authorisation' means that the Fitbit device is approved for use only within the context of the coronavirus pandemic.
It is a low-cost ventilator which can be manufactured quickly, with The Verge reporting that it will be sold for around $5,000 (£4,000). Production is scheduled to begin this month.
The ventilator design is based on the MIT E-Vent project, which provides detailed information about how to automate manual ventilators - a popular option for companies racing to develop ventilators quickly and affordably. The Flow is built around the resuscitator bags used for manual ventilation by paramedics, with ventilation fully automated. It features additional sensors, controls and alarms to assist with patient monitoring.
According to Fitbit, it does not require extensive training to learn to use.
In a statement on his blog, Fitbit CEO James Park 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.”
“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.”
The ventilator is not a like-for-like replacement for the high-cost invasive ventilators used to effectively replace spontaneous breathing for patients critically ill with respiratory complications. Fitbit has suggested that the Flow could be used when more sophisticated invasive ventilators are not available.
The coronavirus pandemic has resulted in an unprecedented surge in demand for ventilators to support patients, particularly invasive ventilators. Invasive ventilators are made by a limited number of healthcare technologies companies, resulting in a scramble for ventilators in many countries.
In the UK, a frantic effort to engage the wider engineering community in the development of new or adapted invasive ventilators has now subsided somewhat. Ventilators quickly designed by engineering companies such as Dyson were ultimately declined by government authorities either due to not meeting the complex specifications necessary for treating Covid-19 patients or due to falling demand. No entirely new invasive ventilator designs have been approved in the UK.
In the US, engineers from Nasa’s Jet Propulsion Laboratory have developed the 'VITAL' ventilator to bridge the gap between invasive ventilation and the most basic assisted breathing equipment; the design received emergency use approval from the FDA at the end of April. Another ventilator design incorporating some of the firm's existing technology remains under development at Tesla.
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