Fitbit has received the go-ahead from regulators in the US and Europe to use the ECG app on its Sense smartwatch – which will not be available to Australian users at launch – to detect atrial fibrillation (AFib).
AFib, an irregular heart rhythm that affects more than 33.5 million people around the world and is difficult to detect, is a risk factor for serious conditions like stroke.
Fitbit’s ECG app for the Sense has received received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, to detect atrial fibrillation; however, the app, which will launch in October 2020, will not initially be available to users in Australia or New Zealand.
In a statement to ChannelNews, Fitbit’s Australian arm said it is working with regulators to bring the ECG app to Australia.
“We are excited to bring this important technology to our users and we were committed to doing so only after thorough testing and development, and by working closely with regulators around the globe including Australia to bring this feature to market soon,” the company said.
According to Eric Friedman, co-founder and CTO, Fitbit has long held assisting users to understand their heart health as a priority.
“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.
“Early detection of AFib 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,” he said.
Sense users can hold their fingers to the stainless steel ring on the watch while staying still for 30 seconds to have their heart rhythm analysed and monitored for signs of AFib. As part of the submission process, a study showed that the ECG app’s algorithm could accurately pick up 98.7 per cent of AFib cases (sensitivity), and was 100 per cent accurate in identifying study participants with normal sinus rhythm (specificity).
Dr Venkatesh Raman, interventional cardiologist at MedStar Georgetown Hospital and Principal Investigator for the U.S. clinical study on Fitbit’s ECG App, said he was “very enthusiastic” about the potential of the ECG app as a tool for detecting possible AFib.
“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,” he said.
The Fitbit Sense is available for preorder online and at selected retailers now, with worldwide availability later this month. It will retail for $499.95 AUD.