FDA Clears ECG App for FitBit’s Wearable Technology

Fitbit’s new electrocardiogram (ECG) app for assessing heart rhythm for atrial fibrillation (AFib) through the company’s latest wearable technology has been cleared for used in the US and Europe.

The company recently announced that the new app received 510(k) clearance from FDA and approval from Conformité Européenne (CE) marketing in the European Union.

The app will help users analyze their heart rhythm for signs of AFib at any moment through an ECG and allow them to review the reading later with their doctor.

“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,” Eric Friedman, Fitbit co-founder and CTO, said in the announcement.

“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.”

As part of Fitbit’s submission process to FDA, the company conducted a multi-site clinical trial in regions across the US, which studied the algorithm’s ability to accurately detect AFib from normal sinus rhythm and generate an ECG trace.

Overall, the study found that the algorithm detected 98.7 percent of AFib cases and was 100 percent accurate in identifying study participants with normal sinus rhythm.

AFib affects 33.5 million individuals globally and can be extremely difficult to detect because an individual may not show symptoms.

An NIH study suggested that 25 percent of individuals who have an AFib-related stoke find out they have AFib only after the stroke occurred.

Fitbit’s new app is the first device that allows on-the-spot reading of an individual’s heart rhythm when they notice unusual cardiac symptoms.

To use the app, individuals hold their fingers to the ring on the watch for 30 seconds to receive a reading that can be downloaded and shared with a healthcare professional.

“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 Venkatesh Raman, MD, interventional cardiologist at MedStar Georgetown Hospital and principal investigator for the US 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.”

The app will be available next month in the US, UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong, and India. 

Throughout the years, Fitbit has been extremely active in the connected health sector. And recently, the company has made an impact on the frontlines of the COVID-19 pandemic. 

At the end of August, Fitbit released data gathered from over 10,000 Fitbit users on the company’s telehealth program.

The data uncovered that mHealth wearables may help providers identify people infected with COVID-19 before symptoms are displayed.

Specifically, nearly 5,000 individuals who developed COVID-19 could be identified as having the virus one day before the onset of symptoms.

The study also helped researchers identify which metrics can signal the onset of the virus and which symptoms are the most likely to lead to hospitalization. 

“This is important because people can transmit the virus before they realize they have symptoms or when they have no symptoms at all,” Conor Heneghan, the company’s director of research and algorithms, said in a statement. 

“If we can let people know they should get tested a day before symptoms begin, they can isolate and seek care sooner, helping to reduce the spread of COVID-19.”