Fitbit ECG App Cleared By FDA For Heart Health Self-Assessment

Today Fitbit was announced to gain FDA clearance for their new ECG app. Fitbit also received a CE mark in the European Union for their ECG app. This app will work with the Fitbit Sense, a wrist-bound smart fitness device that looks a lot like a watch but provides fitness tracking and health features aplenty.

The announcement for the FDA approval – and CE mark – is part of a larger set of announcements for Fitbit's fall device lineup. The Fitbit Sense will have access to the new Fitbit ECG App in October of 2020 as a direct result of this set of approvals.

The app will be available in a select set of countries. Starting in October, you'll be able to download and use the Fitbit ECG App in the United States, United Kingdom, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.

The ECG app was designed by Fitbit to assist users in assessing their own health "in the moment" then "review the reading later with their doctor." Fitbit co-founder and CTE Eric Friedman said, "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."

The Fitbit Sense is already available right this minute (on pre-order) online with a set of retailers and from Fitbit dot com. Broad availability of the device will begin later in the month of September, 2020. This device will be made available for approximately $330 USD in carbon/graphite stainless steel and lunar white/soft gold stainless steel. We'll likely see more devices from Fitbit with access to this app and sensor data in the near future.