Wearables giant Fitbit launched a sweeping heart study on Wednesday aimed at exploring whether its devices can detect atrial fibrillation.
It's part of Fitbit's broader ambitions in healthcare to use its wearable technology for preventive health to reduce the risk of life-threatening events like stroke by detecting problems earlier.
With the launch of the heart study, Fitbit is chasing down competitor Apple which received FDA clearance in 2018 for its ECG feature and more recently launched a study with Johnson & Johnson to explore whether its own wearables can detect Afib.
The company's focus on health care, along with its work in clinical trials to alert users to conditions like hypertension and sleep apnea, makes it clear that it wants to pivot its wearables from just fun accessories to health devices. Fitbit’s user-generated health data, combined with the company’s analytics, can provide an "early warning sign" to users about potential problems like irregular heart rhythms suggestive of atrial fibrillation (Afib), Friedman said.
"It could serve as a 'check engine light' to help get that person to the appropriate level of care, and that could be, at first, a telehealth physician or a personal health coach. That's another layer in the healthcare system. Fitbit devices will be a "Minute Clinic' on your wrist before you have to go see a physician," he said.
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Fitbit's strategy is to make easy-to-use health tools that detect a range of conditions more accessible to the general population, according to the company.
“Until recently, tools for detecting AFib had a number of limitations and were only accessible if you visited a doctor,” said Steven Lubitz, M.D., principal investigator of the Fitbit Heart Study, cardiologist at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School.
“My hope is that advancing research on innovative and accessible technology, like Fitbit devices, will lead to more tools that help improve health outcomes and reduce the impact of AFib on a large scale," Lubitz said.
Fitbit launched in 2007 and now has close to 30 million active users. In November, tech giant Google announced plans to buy the company for $2.1 billion, but that deal still needs to be approved by regulators.
Scripps Research Institute and Stanford Medicine are collaborating with Fitbit on research aimed at using Fitbit data to help detect, track and contain infectious diseases like COVID-19.
The two studies are examples of where Fitbit can fit in healthcare, Friedman said.
The heart study looks at individual wearable data to detect heart health trends and the second study looks at population-level wearable data—including heart rate, sleep, and activity levels—to try to detect the early onset of a virus.
"We're not trying to replace the healthcare system. Doctors and clinicians are dealing with acute healthcare issues and they don't have the bandwidth to look at longitudinal trends," Friedman said. "Where Fitbit wants to play and where we have value is that all-day, continuous health monitoring and guidance to help users stay healthy and manage their health conditions."
Focus on heart health
The Fitbit Heart Study aims to enroll hundreds of thousands of people, and its results will support the company’s regulatory submissions globally.
To track heart rate, Fitbit’s devices use photoplethysmography (PPG) technology to measure the rate of blood flow directly from a user’s wrist. Theoretically, these measurements can be used to determine a user’s heart rhythm, which Fitbit’s algorithm will analyze for irregularities in the Fitbit Heart Study.
Study participants who receive a notification about an irregular heart rhythm will be connected with a doctor for a virtual appointment at no cost and may receive a free electrocardiogram (ECG) patch in the mail to confirm the notification.
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One of the goals of the study is to understand how wearable data and virtual care can be used as a model of healthcare that does not involve in-person care, according to Tony Faranesh, senior research scientist at Fitbit.
"This model of care can be used to both offload the in-person care so the healthcare system can focus on more complicated, more acute health issues, and it's also a way of empowering and educating users about their own health and enabling them to make positive changes before they see a doctor," Faranesh said.
AFib affects nearly 33.5 million people globally and patients with Afib have five times higher risk of stroke. But it also can be difficult to detect.
Fitbit wearables have the potential to accelerate Afib detection because the devices provide 24/7 heart rate tracking. This enables long-term heart rhythm assessment, including when users are asleep. The optimal way to identify irregular rhythm through heart rate tracking technology is to screen when the body is at rest, according to the company.
"We have the opportunity to develop and provide access to technology that may be able to improve public health and save lives," Friedman said.
Fitbit also is pursuing approval from the U.S. Food and Drug Administration and other global regulatory authorities for its Afib detection software.
Fitbit inked a multiyear partnership with pharmaceutical giants Bristol Myers Squibb and Pfizer last year to develop programs to identify and support people found to be at increased risk for stroke. Those programs will be implemented following FDA clearance for Fitbit's Afib detection software.
Fitbit completed a clinical trial of its new ECG feature for spot detection of AFib and plans to seek review by the FDA and global regulatory authorities.