Fitbit receives regulatory clearance in both the United States and Europe for ECG app to identify atrial fibrillation (AFib)

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Fitbit receives regulatory clearance in both the United States and Europe for ECG app to identify atrial fibrillation (AFib)

Press releases may be edited for formatting or style | September 15, 2020 Cardiology

“Physicians are often flying blind as to the day-to-day lives of our patients in between office visits. I’ve long believed in the potential for wearable devices to help us stay better connected, and use real-world, individual data to deliver more informed, personalized care,” said Dr. Venkatesh Raman, interventional cardiologist at MedStar Georgetown Hospital and Principal Investigator for the U.S. clinical study on Fitbit’s ECG App. “Given the toll that AFib continues to take on individuals and families around the world, I’m very enthusiastic about the potential of this tool to help people detect possible AFib, a clinically important rhythm abnormality, even after they leave the physician’s office.”

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.

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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 Studylaunched 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.

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