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With FDA 510(k) clearance and CE mark, the Fitbit ECG App
may help prevent serious complications like stroke by allowing users to spot
check for signs of AFib from their wrist
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The Fitbit ECG App will be available to consumers in
Fitbit (NYSE:FIT) 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 from October 2020 onwards to users on Fitbit SenseTM 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.
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.
As
part of the submission process to regulatory agencies, Fitbit conducted a
multi-site clinical trial in regions across the
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.
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 sensor,
all powered by 6+ days of battery life to help users
take control of their health and wellbeing during this unprecedented time.
Broader 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.
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. Fitbit users
in the
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. Users who receive a notification can
also take a survey in the Fitbit app to share with their doctor.
Availability
Fitbit Sense will be available in