Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app.
San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release.
The Fitbit Sense wearable smartwatch is the company’s first device compatible with the ECG app, allowing users to hold their fingers to the stainless steel ring on the watch while holding still for 30 seconds to get a reading that can then be shared with a doctor.
With an on-wrist skin temperature sensor, an electrodermal activity sensor for managing stress and six or more days of batter life, the device is designed to help users control wellbeing on multiple fronts.
As part of its regulatory submission process, Fitbit conducted a multi-site clinical trial across the U.S. with results showing that its algorithm for detecting AFib exceeded target performance by detecting 98.7% of AFib cases with 100% accuracy in identifying study participants with normal sinus rhythm.
With regulatory clearance, Fitbit plans to launch the ECG app in October to Fitbit Sense users in the U.S., 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,” Fitbit co-founder & CTO Eric Friedman said in the release. “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.”