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

What You Ought to Know:

Effect of Atrial Fibrilliation.

FDA Clearance Submission Process.

— 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 actually gotten 510( k) clearance from the
FDA, as well as CE marking in the European Union, for its ECG
app to examine heart rhythm for atrial fibrillation. The Fitbit ECG App is a.
simple way individuals can take an on-the-spot reading of their heart rhythm at any.
time, including whenever they notice any uncommon heart signs..

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

Fitbits brand-new on-device suitable ECG app assists analyze the.
hearts rhythm for indications of AFib. ECG is a measurement of the electrical.
activity of the heart, and the Fitbit ECG App is a simple way individuals can take.
an on-the-spot reading of their heart rhythm at any time, including whenever.
they discover any uncommon heart signs.

In May 2020, the Fitbit Heart Study.
launched to confirm using Fitbits PPG technology to identify episodes of.
irregular heart rhythm suggestive of AFib. In simply over 4 months, the Fitbit.
Heart Study has registered more than 400,000 individuals.7 Fitbit users in the.
United States interested in participating can visit the study site or open.
the Fitbit app to find the Fitbit Heart Study on the Discover tab under.
Assessments & & Reports. The outcomes of the study will be utilized to support.
Fitbits regulative submissions worldwide for its long-lasting heart rhythm.
assessment function.

As part of the submission procedure to regulatory agencies,.
Fitbit conducted a multi-site scientific trial in areas across the U.S. The.
research study assessed our algorithms ability to properly identify AFib from typical.
sinus rhythm and to create an ECG trace, or recording of a hearts electrical.
rhythm, that is qualitatively similar to a Lead I ECG. The study showed that.
the algorithm exceeded target efficiency, showing the ability to find.
98.7% of AFib cases (sensitivity) and was 100% precise in identifying study.
participants with typical sinus rhythm (uniqueness).

Fitbit has actually received.
510( k) clearance from the U.S. Food and Drug Administration (FDA), in addition to.
Conformité Européenne (CE) marking in the European Union, for its.
electrocardiogram (ECG) app to examine heart rhythm for atrial fibrillation.
( AFib), a condition that affects more than 33.5 million individuals internationally. The.
Fitbit ECG App, revealed in Fitbits recent fall item.
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.

How Fitbit Sense Works.

Cardiovascular disease continues to be the leading cause of death.
worldwide, regardless of being among the most preventable conditions. AFib, an.
irregular heart rhythm that increases the risk of major issues like.
stroke, can be particularly difficult to identify, as episodes can often show.
no symptoms. Some studies suggest that as many as 25 percent of individuals who have.
an AFib-related stroke find out they have AFib only after a stroke has.
occurred.

The new ECG app is part of Fitbits broader method to.
heart health innovation. Fitbit pioneered using heart rate tracking on the.
wrist with its PurePulse innovation in 2014, which uses photoplethysmography.
( or PPG) to keep track of the small blood volume fluctuations in the wrist as the.
heart beats, and we continue to establish ingenious tools that help individuals.
much better understand and handle their heart health.

ECG App Reflects Fitbits Commitment to Heart Health.

Fitbit Sense is the businesss first device suitable with.
an ECG app that allows users to take a spot check reading of their heart that.
can be analyzed for the heart rhythm irregularity AFib. Users just 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 shown a physician.
Fitbit Sense is the companys most sophisticated health smartwatch, with the worlds.
Electrodermal activity (EDA) sensing unit on a smartwatch to assist manage.
tension, 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 throughout.
this extraordinary time.

Recent Fitbit Heart Study.

— Fitbit Sense is the businesss first gadget compatible.
with an ECG app that makes it possible for users to take a check reading of their heart.
that can be examined for the heart rhythm abnormality AFib.

Schedule.

Continuing the legacy of heart health development, Fitbit.
released PurePulse 2.0 in August 2020, providing the businesss most advanced.
heart rate innovation yet, utilizing a brand new multi-path heart rate sensing unit and.
enhanced algorithm. This enhanced innovation provides users with on-device and.
If their heart rate goes above or below their set heart, in-app notices.
rate limit.8 Users who get a notice can also take a study in the.
Fitbit app to share with their doctor.

< Both long-lasting heart rhythm assessment (PPG) and check. ( ECG) innovation have crucial functions to play and Fitbit aims to offer both. choices to users based on their individual requirements. Long-lasting heart rhythm. evaluation could provide our users the capability to recognize asymptomatic AFib that. could otherwise go undetected, while a spot check technique with new Fitbit ECG. App can assist those who wish to evaluate themselves for possible AFib and record. an ECG trace they can review with their health care supplier.