Fitbit has received 510(k) clearance from the US 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 (AF).
The Fitbit ECG app will be available in October 2020 to users on Fitbit Sense in the following countries: the USA, UK, Germany, Austria, Luxembourg, The Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.
“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit co-founder and CTO. “Early detection of AF is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions and potentially save lives.”
As part of the submission process to regulatory agencies, Fitbit conducted a multi-site clinical trial in regions across the USA. The study evaluated the algorithm’s ability to accurately detect AF 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 AF cases (sensitivity) and was 100% accurate in identifying study participants with normal sinus rhythm (specificity).
Fitbit’s new on-device compatible ECG app helps analyse the heart’s rhythm for signs of AF.
“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, personalised care,” said Venkatesh Raman, interventional cardiologist at MedStar Georgetown Hospital and Principal Investigator for the US clinical study on Fitbit’s ECG App. “Given the toll that AF 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 analysed for the heart rhythm irregularity AF. Users 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.