Fitbit and FibriCheck announce expansion of partnership to deliver CE-marked health app to more Fitbit smartwatch users in Europe

Fitbit users in France, Germany, Italy and Spain can use FibriCheck to help detect heart rhythm irregularities like Atrial Fibrillation

[Dublin – March 3, 2020] Fitbit (NYSE:FIT) and FibriCheck, an innovative health screening and monitoring app, today announced a partnership enabling users in France, Germany Italy and Spain to monitor their heart rhythm for irregularities, such as Atrial Fibrillation (Afib) directly from their Fitbit smartwatch. The FibriCheck software, which is CE marked, meets the performance standards for medical devices in the European Union (EU).

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 2035¹.

“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,” said Nicola Maxwell, Director of Health Solutions & Services, EMEA for Fitbit. “FibriCheck became the first CE-marked app to be available on Fitbit smartwatches in the EU last year, and the expansion of our partnership to users in France, Germany, Italy and Spain reflects our commitment to provide technology-based solutions that can help drive positive health outcomes.”

FibriCheck on Fitbit smartwatches first launched in September 2019 to Fitbit users in Belgium, Ireland, the Netherlands, and the UK. Since it launched on Fitbit OS, over 150,000 heart rhythm measurements have been taken by users on their Fitbit smartwatch.

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 is an easy-to-use, first step for people who have concerns about their heart health or who have been advised to monitor their heart rhythm consistently by a medical professional,” said Lars Grieten, CEO, FibriCheck. “By partnering with Fitbit, we are bringing our technology to millions of consumers’ wrists regardless of mobile device platform, and it provides an accessible option for consumers to better understand their heart health and then easily share those insights with a medical professional who can support their care.”

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. A FibriCheck reading can be completed in 60 seconds. Instant, color-coded feedback is sent directly to the smartwatch screen; from green indicating that no irregularities have been detected, to red, which advises users to seek medical advice. A detailed report is also available via the FibriCheck smartphone app, which can be shared with medical professionals.

Fitbit helps people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals. Fitbit designs products and experiences that track and provide motivation for everyday health and fitness. Fitbit’s diverse line of innovative and popular products include Fitbit Charge 3™, Fitbit Inspire HR™, Fitbit Inspire™ and Fitbit Ace 2™ activity trackers, as well as the Fitbit Ionic™ and Fitbit Versa™ family of smartwatches, Fitbit Flyer™ wireless headphones, and Fitbit Aria family of smart scales. Fitbit products are carried in approximately 39,000 retail stores and in 100+ countries around the globe. Powered by one of the world’s largest databases of activity, exercise and sleep data and Fitbit’s leading health and fitness social network, the Fitbit platform delivers personalized experiences, insights and guidance through leading software and interactive tools, including the Fitbit and Fitbit Coach apps, and Fitbit OS for smartwatches. Fitbit’s paid subscription service, Fitbit Premium, uses your unique data to deliver actionable guidance and coaching in the Fitbit app to help you reach your health and fitness goals. Fitbit Health Solutions develops health and wellness solutions designed to help increase engagement, improve health outcomes, and drive a positive return for employers, health plans and health systems.

Fitbit and the Fitbit logo are trademarks or registered trademarks of Fitbit, Inc. in the U.S. and other countries. Additional Fitbit trademarks can be found www.fitbit.com/legal/trademark-list. Third-party trademarks are the property of their respective owners.

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FibriCheck’s mission is to make healthcare widely available, affordable and unlinked to time and location. Fibricheck targets the prevention of possibly life-threatening and disabling strokes by enabling early detection of heart rhythm disorders, with a main focus on atrial fibrillation (Afib).

Fibricheck makes the detection of heart rhythm disorders possible with just a smartphone or smartwatch using the clinically validated PPG technology. The CE-marked application turns heart rhythm monitoring into an at-home solution that can be used by anyone at anytime, without the need for extra hardware. FibriCheck is currently helping over 200,000 people in 43 countries and is prescribed by more than 1,500 doctors, enabling the detection of more than 16,000 heart rhythm disorders so far.

FibriCheck is a registered trademark of Qompium nv. in the EU and US.

This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties including, among other things, statements regarding the future availability of any product features or services described in this release, future potential of the FibriCheck app described in this release; and our ability to help users manage or improve their health and wellness. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors, including the effects of the highly competitive market in which we operate, including competition from much larger technology companies; any inability to successfully develop and introduce new products, features, and services or enhance existing products and services; product liability issues, security breaches or other defects; and other factors discussed under the heading “Risk Factors” in our most recent report on Form 10-Q filed with the Securities and Exchange Commission. All forward-looking statements contained herein are based on information available to us as of the date hereof and we do not assume any obligation to update these statements as a result of new information or future events.

¹ “The Burden of Stroke in Europe Report | King’s College London for the ….” https://strokeeurope.eu/. Accessed 3 Sep. 2019.