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Fitbit Awarded Regulatory Clearance in U.S. and Europe for ECG App to Identify AFib

What You Should Know:

– Fitbit has received 510(k) clearance from the
FDA, as well as CE marking in the European Union, for its ECG
app to assess heart rhythm for atrial fibrillation. The Fitbit ECG App is a
simple way people can take an on-the-spot reading of their heart rhythm at any
time, including whenever they notice any unusual cardiac symptoms. 

– Fitbit Sense is the company’s first device compatible
with an ECG app that enables users to take a spot check reading of their heart
that can be analyzed for the heart rhythm irregularity AFib.

– Fitbit Sense is available today for pre-order on
Fitbit.com and online at select retailers for $329.95 (USD) in carbon/graphite
stainless steel and lunar white/soft gold stainless steel.


Fitbit has received
510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as
Conformité Européenne (CE) marking in the European Union, for its
electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation
(AFib), a condition that affects more than 33.5 million people globally. The
Fitbit ECG App, unveiled in Fitbit’s recent fall product
launch
, will be available in October 2020 to users on Fitbit
Sense
in the following countries: the United States, United Kingdom,
Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech
Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France,
Hong Kong and India.

FDA Clearance Submission Process

As part of the submission process to regulatory agencies,
Fitbit conducted a multi-site clinical trial in regions across the U.S. The
study evaluated our algorithm’s ability to accurately detect AFib from normal
sinus rhythm and to generate an ECG trace, or recording of a heart’s electrical
rhythm, that is qualitatively similar to a Lead I ECG. The study showed that
the algorithm exceeded target performance, demonstrating the ability to detect
98.7% of AFib cases (sensitivity) and was 100% accurate in identifying study
participants with normal sinus rhythm (specificity).

Fitbit’s new on-device compatible ECG app helps analyze the
heart’s rhythm for signs of AFib. ECG is a measurement of the electrical
activity of the heart, and the Fitbit ECG App is a simple way people can take
an on-the-spot reading of their heart rhythm at any time, including whenever
they notice any unusual cardiac symptoms.

How Fitbit Sense Works

Fitbit Sense is the company’s first device compatible with
an ECG app that enables users to take a spot check reading of their heart that
can be analyzed for the heart rhythm irregularity AFib. Users simply hold their
fingers to the stainless steel ring on the watch while being still for 30
seconds to get a reading that can be downloaded and shared with a doctor.
Fitbit Sense is the company’s most advanced health smartwatch, with the world’s
first electrodermal activity (EDA) sensor on a smartwatch to help manage
stress, and an on-wrist skin temperature sensor5, all powered by 6+ days of
battery life6 to help users take control of their health and wellbeing during
this unprecedented time.

Impact of Atrial Fibrilliation

Heart disease continues to be the leading cause of death
worldwide, despite being one of the most preventable conditions. AFib, an
irregular heart rhythm that increases the risk of serious complications like
stroke, can be particularly difficult to detect, as episodes can sometimes show
no symptoms. Some studies suggest that as many as 25 percent of people who have
an AFib-related stroke find out they have AFib only after a stroke has
occurred.

ECG App Reflects Fitbit’s Commitment to Heart Health

The new ECG app is part of Fitbit’s broader approach to
heart health innovation. Fitbit pioneered the use of heart rate tracking on the
wrist with its PurePulse technology in 2014, which uses photoplethysmography
(or PPG) to monitor the tiny blood volume fluctuations in the wrist as the
heart beats, and we continue to develop innovative tools that help people
better understand and manage their heart health.

Both long-term heart rhythm assessment (PPG) and spot check
(ECG) technology have important roles to play and Fitbit aims to provide both
options to users based on their individual needs. Long-term heart rhythm
assessment could give our users the ability to identify asymptomatic AFib that
could otherwise go undetected, while a spot check approach with new Fitbit ECG
App can help those who want to screen themselves for possible AFib and record
an ECG trace they can review with their healthcare provider.

Recent Fitbit Heart Study

In May 2020, the Fitbit Heart Study
launched to validate the use of Fitbit’s PPG technology to identify episodes of
irregular heart rhythm suggestive of AFib. In just over four months, the Fitbit
Heart Study has enrolled more than 400,000 participants.7 Fitbit users in the
United States interested in participating can visit the study website or open
the Fitbit app to find the Fitbit Heart Study on the Discover tab under
Assessments & Reports. The results of the study will be used to support
Fitbit’s regulatory submissions globally for its long-term heart rhythm
assessment feature.

Continuing the legacy of heart health innovation, Fitbit
released PurePulse 2.0 in August 2020, delivering the company’s most advanced
heart rate technology yet, using an all-new multi-path heart rate sensor and
improved algorithm. This enhanced technology provides users with on-device and
in-app notifications if their heart rate goes above or below their set heart
rate threshold.8 Users who receive a notification can also take a survey in the
Fitbit app to share with their doctor.

Availability

Fitbit Sense is available today for pre-order on Fitbit.com
and online at select retailers, with broad worldwide availability starting
later this month. Fitbit Sense is available for $329.95 (USD) in
carbon/graphite stainless steel and lunar white/soft gold stainless steel.

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