“Emergency Use Authorization”, which the ventilator received, means that it can only be used to treat patients during the pandemic.
While Fitbit, which was purchased by Google for $2.1 billion in 2019, is aiming to provide these devices around the world to health institutions that do not have access to commercial ventilators. They are only intended to be used when other ventilators are not available.
The ventilator has not been FDA cleared or approved, so it will require further examination in order to prove that it is “substantially equivalent to another (similar) legally marketed device” for clearance, or that the “benefits of the product outweigh the known risks for the intended use” for approval.
The Flow is an automatic resuscitator with a design based on MIT’s E-Vent Design Toolbox. The company says that it builds on resuscitator bags used by paramedics, with sensors and alarms to support automatic compression and to monitor patients.
Fitbit says that while other emergency ventilators vary when it comes to the features they offer, the Flow undercuts them on both price and feature range. The Independent has reached out to Fitbit for more detail about exactly what sensors the Flow has.
The company is intending to sell the Flow for approximately $5,000 (£4,000), and that production of the ventilator will start this month, Fitbit told The Verge.
“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,” James Park, co-founder and CEO of Fitbit said in a statement.
“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.”
“US 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 New England Journal of Medicine said.
Fitbit is not the only company making emergency ventilators during the coronavirus pandemic. Vacuum cleaner manufacturer Dyson designed a ventilator to fill a 10,000-strong order from the UK government but it was later reported that it would not be used.
Tesla CEO Elon Musk also offered free ventilators to hospitals and promised 1,000 to California. However, these ventilators reportedly did not arrive in time and would not be available for the apex of the coronavirus pandemic.
A number of other firms have been involved in designing ventilators, including Airbus, Smiths Group Plc, Ford Motor Co and McLaren.