Study part of broader Company efforts to
make health tools more accessible and reduce the risk of
life-threatening events like stroke
Fitbit (NYSE: FIT) today launched the Fitbit Heart Study, its
first large-scale, virtual study to validate the use of its
wearable technology to identify episodes of irregular heart rhythm
suggestive of atrial fibrillation (AFib), the most common form of
heart rhythm irregularity. This study is part of the Company’s
broader strategy to make easy-to-use tools that accelerate
detection of a range of conditions more accessible. The Fitbit
Heart Study aims to enroll hundreds of thousands of people, and its
results will support the Company’s regulatory submissions
globally.
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The Fitbit Heart Study is part of
Fitbit’s broader strategy to make health tools more accessible and
reduce the risk of life-threatening events like stroke. (Graphic:
Business Wire)
AFib affects nearly 33.5 million people globally1 and patients
with AFib have a five times higher risk of stroke.2 3 It can also
be difficult to detect, as episodes can be sporadic and
asymptomatic, and some studies suggest that as many as 25 percent
of people who have an AFib-related stroke only find out they have
AFib after a stroke has occurred.4
“Until recently, tools for detecting AFib had a number of
limitations and were only accessible if you visited a doctor,” said
Steven Lubitz, M.D., M.P.H, principal investigator of the Fitbit
Heart Study, cardiologist at Massachusetts General Hospital and
Associate Professor of Medicine at Harvard Medical School. “My hope
is that advancing research on innovative and accessible technology,
like Fitbit devices, will lead to more tools that help improve
health outcomes and reduce the impact of AFib on a large
scale.”
Fitbit wearables have the unique potential to accelerate AFib
detection because their 24/7 heart rate tracking is powered by long
battery life, which allows users to wear their device for multiple
days at a time. This enables long-term heart rhythm assessment,
including when users are asleep. The optimal way to identify
irregular rhythm through heart rate tracking technology is to
screen when the body is at rest, making assessment overnight, while
people sleep, ideal for detection.
“Since we first brought heart rate tracking to the wrist in
2015, we have continued to innovate and provide users with a deeper
understanding of their heart health through features like Sleep
Stages, Cardio Fitness Level and now Active Zone Minutes,” said
Eric Friedman, Fitbit co-founder and CTO. “The Fitbit Heart Study
advances our heart health efforts. Long-term passive heart rhythm
assessment with our wide range of affordable devices powered by
24/7 heart rate tracking technology has the potential to improve
earlier identification of AFib, which is a key to reducing the risk
of a life-threatening event like stroke. By doing this important
research we have the opportunity to develop and provide access to
technology that may be able to improve public health and save
lives.”
To track heart rate, Fitbit’s devices use photoplethysmography
(PPG) technology to measure the rate of blood flow directly from a
user’s wrist. Theoretically, these measurements can be used to
determine a user’s heart rhythm, which Fitbit’s algorithm will
analyze for irregularities in the Fitbit Heart Study. Study
participants who receive a notification about an irregular heart
rhythm will be connected with a doctor for a virtual appointment at
no cost to get more information and may receive an
electrocardiogram (ECG) patch in the mail at no cost to confirm the
notification.
Broader commitment to heart health
The Fitbit Heart Study is part of Fitbit’s broader approach to
heart health innovation, which includes industry partnerships and
the development of other technologies focused on raising awareness
and accelerating detection of AFib to reduce the risk of stroke and
improve population health. In addition to the technology being
examined in the Fitbit Heart Study, the company has made
significant progress in the development of a new electrocardiogram
(ECG) feature for spot detection of AFib.
Fitbit aims to provide users with both long- and short-term AFib
assessment options based on their individual needs and is
developing PPG and ECG tools that could offer both long-term
assessment and spot-check AFib detection. The Fitbit PPG-based
heart rhythm tool is designed to identify irregular rhythm episodes
with no symptoms that might otherwise go undetected, and the Fitbit
ECG feature is designed to support those who want to screen
themselves for possible AFib and record an ECG trace they can
review with their doctor. The Company has completed a pivotal
clinical trial of its new ECG feature and plans to seek review by
the U.S. Food and Drug Administration (FDA) and global regulatory
authorities.
Additionally, following FDA clearance for the PPG AFib
algorithm, Fitbit will continue to work with the Bristol-Myers
Squibb-Pfizer Alliance to develop programs and educational content
that will help identify and support people in the U.S. at increased
risk for stroke to provide a continuous and supported care pathway
that extends to AFib diagnosis.
How to join the Fitbit Heart Study
The study is open to people in the United States ages 22 years
and older with a current Fitbit device that tracks heart rate,
including Fitbit IonicTM, Fitbit VersaTM family of smart watches,
Fitbit Charge 3TM, Fitbit Charge 4TM, and Fitbit Inspire HRTM.
Participant data will be kept confidential and will only be shared
with study partners in connection with the study. For more details
on the Fitbit Heart Study or to enroll, visit the Fitbit Heart
Study website. The study will support the clinical evaluation of
the Company’s PPG AFib algorithm, including whether it can
successfully identify episodes of irregular heart rhythm.
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
www.fitbit.com/legal/trademark-list. Third-party trademarks are the
property of their respective owners.
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Fitbit experience.
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 of our products to
identify or detect AFib; and progress developing our ECG or PPG
features, including but not limited to submission of such products
to the FDA. 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-K 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.
1Chugh S, Havmoeller R, Narayanan K, Singh D, Rienstra M,
Benjamin E, Gillum R, Kim YH, McAnulty Jr JH, Zheng ZJ. Worldwide
Epidemiology of Atrial Fibrillation: Global Burden of Disease 2010
Study. Circulation. 2014; 129: 837-847
2January CT, Wann LS, Alpert JS, et al. American College of
Cardiology/American Heart Association Task Force on Practice
Guidelines. 2014 AHA/ACC/HRS guideline for the management of
patients with atrial fibrillation. A report of the American College
of Cardiology/American Heart Association Task Force on practice
guidelines and the Heart Rhythm Society. J Am Coll Cardiol.
2014;64(21):e1-e76
3Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation is an
independent risk factor for stroke: The Framingham Study. Stroke.
1991;22(8):983-988.
4Freedman B, Potpara TS, Lip GY. Stroke prevention in atrial
fibrillation. Lancet. 2016;388:806–817
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Jen Ralls 415-941-0037, PR@Fitbit.com
Fitbit (NYSE:FIT)
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