Fitbit gets FDA clearance for its Sense smartwatch and ECG app
Fitbit’s $329 Sense smartwatch just earned clearance from the FDA (and the EU’s regulatory body) for its electrocardiogram (ECG) app. When the “advanced health” wearable arrives this October, it will be able to assess heart rhythms for atrial fibrillation, or AFib.
AFib is a heart condition that affects more than 33.5 million people globally and has serious complications, including stroke. The condition is notoriously difficult to detect because the heart doesn’t always present an abnormal rhythm when a patient is in their doctor’s office. A study used to evaluate Fitbit’s algorithm found that it could detect 98.7 percent of AFib cases.