FibriCheck to deliver CE-marked heart health detection app to Fitbit smartwatch users in Europe

Fitbit FibriCheck

Fitbit has partnered with the maker of a health screening and monitoring app FibriCheck to enable users in Belgium, the Netherlands, Ireland and the UK to monitor their heart rhythm for irregularities, such as Atrial Fibrillation (Afib) directly from their Fitbit smartwatch. The CE marked FibriCheck software meets the performance standards for medical devices in the European Union.

The FibriCheck app runs on Fitbit OS and uses Fitbit’s commercial-grade PPG (photoplethysmography) sensors — light-based technology that measures the rate of blood flow — to capture heart rhythm measurements from a user’s wrist. The measurement assessment can be viewed directly on the smartwatch screen and easily shared with medical professionals via a FibriCheck web interface to help diagnose conditions such as Afib. Afib, an irregular heart rhythm that is often difficult to detect or diagnose because of irregular occurrences, is a leading cause of stroke, the occurrence of which in Europe is predicted to increase to more than 800,000 by 2035.

“For more than a decade, Fitbit has helped millions of consumers around the world get healthier by providing them with a holistic picture of their health and wellness. Our partnership with FibriCheck expands on this vision by offering an accessible way for people to detect irregular heart rhythms using their Fitbit smartwatch, helping them to potentially identify and monitor heart conditions like atrial fibrillation,” Nicola Maxwell, Director of Health Solutions & Services, EMEA for Fitbit, said in a statement. “FibriCheck is the first CE-marked app to be available on Fitbit smartwatches in the EU and its addition to the platform complements our expanding range of technology-based solutions that can help drive positive health outcomes.”

The FibriCheck smartphone app has been available for users to measure their heart rhythm via the camera on their smartphones since 2016. A clinical trial was conducted to validate and support CE Marking of the FibriCheck application on Fitbit smartwatches. The trial compared FibriCheck on Fitbit smartwatches to gold-standard 12-lead ECG and state-of-the-art wearable single lead ECG technologies. The results indicated that the FibriCheck algorithm on Fitbit smartwatches was highly accurate in correctly detecting the presence of Afib when compared to ECG. As a result, this industry-leading partnership between Fitbit and FibriCheck will make trusted heart health monitoring accessible to more consumers in Europe.

FibriCheck will be available on Fitbit Versa, Fitbit Versa Lite Edition, Fitbit Versa 2 and Fitbit Ionic devices and can be accessed through the Fitbit app gallery on smartphones. FibriCheck has a subscription model starting at €3.99 per month and a one-day free trial is available.