Smartwatch app to detect AF receives FDA clearance
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Fitbit announced that an ECG app to identify atrial fibrillation through its smartwatch has received 510(k) clearance from the FDA.
The app, which will be used in conjunction with a smartwatch (Fitbit Sense), allows patients to take an ECG at any time, especially when they suspect unusual cardiac symptoms, according to a press release from the company.
“FDA clearance is essential to bring Fitbit’s ECG atrial fibrillation detection capability to consumers,” Venkatesh Raman, MD, assistant professor of medicine at Georgetown University School of Medicine and medical director of the cardiac catheterization laboratory at MedStar Georgetown University Hospital, told Healio. “This represents another important step toward realizing the potential of mobile health to favorably impact lives.”
Patients use their fingers to hold a stainless steel ring on the watch for 30 seconds while it obtains a reading, which can be shared and downloaded with their doctor.
“A proportion of people with AF are undiagnosed and at risk for stroke and other adverse events,” Raman said in an interview. “A wearable that allows the engaged consumer to check their heart rhythm in real time, perhaps for symptoms or simply feedback, may help triage some with possible AF to seek additional care. Confirmation and stratification by providers can identify those at elevated risk who may benefit from standard therapies such as blood thinners to help prevent stroke.”
Raman added that this technology adds to the changing landscape of mobile health. He told Healio: “Sensors are smaller, more sophisticated and increasingly ubiquitous in consumer devices. Equally important are advances in personal computing and software that permit real-time analysis to transform data into actionable output for the user. Combining these in a wristband device with familiar form and function provides a powerful platform for the ongoing evolution of mobile health.”
A multisite clinical trial was conducted in the U.S. which assessed the algorithm’s ability to detect AF and to produce an ECG trace similar to a lead-1 ECG. The study, for which Raman was a principal investigator, found that the algorithm had 98.7% sensitivity and 100% specificity.
A validation study — the Fitbit Heart Study — launched in May and continues to enroll patients through the study’s website or the Fitbit app. The study enrolled more than 400,000 patients since its launch, according to the release.
“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 chief technology officer, said in the release. “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.”
The application will be available October in several countries, including the United States, according to the release.
For more information:
Venkatesh Raman, MD, can be reached at 3800 Reservoir Rd. Northwest, 5th Floor, Washington, D.C. 20007.
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