Fitbit Flow has been granted Emergency Use
Authorization by the FDA
Fitbit (NYSE: FIT) today announced it has developed a
high-quality, low-cost, easy-to-use emergency ventilator, Fitbit
Flow, which has obtained Emergency Use Authorization (EUA) from the
U.S. Food & Drug Administration (FDA) for use during the
COVID-19 public health emergency.
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the full release here:
https://www.businesswire.com/news/home/20200603005785/en/
Fitbit Flow, a low-cost, easy-to-use
emergency ventilator, builds on standard resuscitator bags, like
those used by paramedics, with sophisticated instruments, sensors,
and alarms that work together to support automated compressions and
patient monitoring. Fitbit Flow has obtained Emergency Use
Authorization from the FDA for use during the COVID-19 pandemic.
(Photo: Business Wire)
After seeing the global need for ventilators, Fitbit applied its
deep in-house expertise in advanced sensor development and hardware
design to quickly create Fitbit Flow, an automatic resuscitator
inspired by the MIT E-Vent Design Toolbox and based on
specifications for Rapidly Manufactured Ventilation Systems. During
development and testing, Fitbit consulted with Oregon Health &
Science University emergency medicine clinicians caring for
COVID-19 patients at OHSU Hospital and worked with the Mass General
Brigham Center for COVID Innovation working group on the design to
meet the needs of practitioners.
“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. “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 Flow builds on standard resuscitator bags, like those
used by paramedics, with sophisticated instruments, sensors, and
alarms that work together to support automated compressions and
patient monitoring. The device is designed to be intuitive and
simple to use, potentially helping to reduce the strain on
specialized staff who are typically needed to operate a commercial
ventilator. Other similar emergency ventilators vary in the
combination of features they offer, but Fitbit believes that none
delivers all of the attributes of its device at the same lower
price range.
According to the New England Journal of Medicine, “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.”
“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 Oregon Health & Science
University.
Fitbit aims to leverage the company’s vast infrastructure and
manufacturing capabilities that currently produces millions of
Fitbit devices per year to produce large volumes of these emergency
devices quickly. The goal is to supply these devices to health care
systems around the world that do not have a sufficient number of
traditional commercial ventilators. Fitbit Flow is designed to be
used only when a traditional commercial ventilator is not
available.1
Fitbit is in talks with state and federal agencies to understand
current domestic needs for emergency ventilators and plans to work
with U.S. and global aid organizations as well, both today and
ahead of any future waves of the virus.
About Fitbit, Inc. (NYSE: FIT)
Fitbit helps people lead healthier, more active lives by
empowering them with data, inspiration and guidance to reach their
goals. Fitbit designs products and experiences that track and
provide motivation for everyday health and fitness. Fitbit’s
diverse line of innovative and popular products include Fitbit
Charge 4™, Fitbit Charge 3™, Fitbit Inspire HR™, Fitbit Inspire™
and Fitbit Ace 2™ activity trackers, as well as the Fitbit Ionic™
and Fitbit Versa™ family of smartwatches, Fitbit Flyer™ wireless
headphones, and Fitbit Aria family of smart scales. Fitbit products
are carried in approximately 39,000 retail stores and in 100+
countries around the globe. Powered by one of the world’s largest
databases of activity, exercise and sleep data and Fitbit’s leading
health and fitness social network, the Fitbit platform delivers
personalized experiences, insights and guidance through leading
software and interactive tools, including the Fitbit and Fitbit
Coach apps, and Fitbit OS for smartwatches. Fitbit’s paid
subscription service, Fitbit Premium, uses your unique data to
deliver actionable guidance and coaching in the Fitbit app to help
you reach your health and fitness goals. Fitbit Health Solutions
develops health and wellness solutions designed to help increase
engagement, improve health outcomes, and drive a positive return
for employers, health plans and health systems.
Fitbit and the Fitbit logo are trademarks or registered
trademarks of Fitbit, Inc. in the U.S. and other countries.
Additional Fitbit trademarks can be found at
www.fitbit.com/legal/trademark-list. Third-party trademarks are the
property of their respective owners.
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Forward Looking Statement
This press release contains forward-looking statements, within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, that involve risks and uncertainties
including, among other things, statements about the attributes and
pricing of Fitbit Flow. These forward-looking statements are only
predictions and may differ materially from actual results due to a
variety of factors, including the effects of the highly competitive
market in which we operate, including competition from much larger
technology companies; any inability to successfully develop and
introduce new products, features, and services or enhance existing
products and services; product liability issues, security breaches
or other defects; the impact of the recent outbreak of the COVID-19
virus; and other factors discussed under the heading “Risk Factors”
in our most recent report on Form 10-Q filed with the Securities
and Exchange Commission. All forward-looking statements contained
herein are based on information available to us as of the date
hereof and we do not assume any obligation to update these
statements as a result of new information or future events.
____________________________
1 Fitbit Flow has been authorized by FDA under an EUA for use
during the COVID-19 public health emergency. It is not FDA cleared
or approved.
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version on businesswire.com: https://www.businesswire.com/news/home/20200603005785/en/
Fitbit, Inc. Media: Jen Ralls 415-941-0037, PR@Fitbit.com
Fitbit (NYSE:FIT)
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