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Empatica’s Year in Review

If 2020 was the year in which the world changed, then 2021 was the year of transitioning to a new reality, and this has been no different for Empatica. There were many uncertainties and hardships to overcome for all of us as we entered 2021, but filled with passion and determination, we stayed true to our mission and reached new milestones.

Our goal remains to create the world’s biggest and most accurate digital biomarker platform to improve health outcomes. Building on all the great foundations we set in 2020, in 2021 we continued to embrace innovation while helping our clients and partners reach unexplored frontiers in their research.

EmbracePlus is already being used in dozens of clinical studies

Last year, after years of hard work, we finally produced the very first EmbracePlus units. Today, we are proud to share that our clinical operations have grown to dozens of studies that are currently using EmbracePlus and our platform, including some of the top 25 pharmaceutical companies for their decentralized trials. Other highlights include our partnership with Pear Therapeutics to explore withdrawal symptoms in people suffering from opioid abuse, and the EU H2020 project, with EmbracePlus being used in two innovative studies on sleep and ADHD.

EmbracePlus and Care awarded the CE Mark as a Class IIa medical device

In April, EmbracePlus reached another landmark moment: alongside our remote monitoring suite, Empatica Care, EmbracePlus received the European CE mark as a Class lla medical device for its ability to consistently provide quality physiological parameters to its users. The CE mark was an important first step in establishing EmbracePlus as the world’s most advanced and accurate medical smartwatch. You can read the Declaration of Conformity here.

Not only has it been awarded status as a medical device, EmbracePlus also received recognition from the Industrial Designers Society of America, by being a Featured Finalist in the prestigious IDEA 2021 awards: a stamp of approval on how its beautiful design makes it the missing link between medical and consumer devices!

We built on our data work by validating 5 digital biomarkers and publishing new papers

Our products are built to provide clinical-grade data from the real world while reducing patient and site burden. Our efforts on this start with the robust development and validation of digital biomarkers, which can be applied in real-life use cases. In record time, and as part of our FDA submission, we conducted studies to validate digital biomarkers for Pulse Rate, Pulse Rate Variability, Respiratory Rate, Oxygen Saturation (SpO2), and On-wrist detection (a behavioural digital biomarker which can detect when the EmbracePlus is being worn or not, thus eliminating false readings).

Our researchers were also busy with the publication of multiple papers, with one of the highlights being our paper on Sleep assessment by means of a wrist actigraphy-based algorithm: agreement with polysomnography in an ambulatory study on older adults. The paper provided evidence of promising performance of a full-automation of the sleep tracking procedure using an actigraphy-based sleep algorithm on older adults.

Meanwhile, our paper in Frontiers in Neurology on the Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit further established the capabilities of our algorithm in detecting convulsive seizures, using our FDA-cleared Embrace2. This was the first prospective study on a multimodal wearable CS detection system based on wrist ACM and EDA sensors evaluated on a large patients’ pool (152 patients).

Began testing the EmbracePlus SDK

One of the most exciting product developments we have in the pipeline is the release of the new EmbracePlus SDK, which will open up unprecedented capabilities for remote health monitoring, across industries. With its plug-and-play nature, the SDK will allow developers to incorporate EmbracePlus data inside their infrastructure, whether that is a platform that already exists, or a new application. We will share more on this early in the new year! In the meantime, you can visit our Platform page which outlines some of the potential applications, or talk to our team if you require more information.

Continued the battle against Covid-19

Following last year’s partnerships with the USAMRDC and HHS/BARDA, we completed our Covid-19 trials, across multiple sites, in order to validate our respiratory infection early detection algorithm.

The algorithm received a first-of-its-kind CE mark in March. This still makes it the only commercially available solution in Europe that uses an algorithm and specifically provides an early warning to its users when changes in their physiology indicate the onset of a respiratory infection.

Embraced the post-Covid, remote-friendly world

Like many other teams across the globe, the Empatica team embraced the remote/hybrid model. We have had the fortune of spending time together, getting to know new faces, having team meetups, and even attending some events in person, by adopting a working model that accommodates everyone’s unique situation, and empowers every Empatican to do their best work.

And, despite the distance, we feel closer to each other than ever, thanks to working together on solutions that can have a true impact and change people’s lives. Empatica is also proud to be 50% female, which is almost twice the industry average. We will continue to promote diversity and equal opportunities among all our employees across the world.

If you are curious about the positions we currently have open, visit our Careers page. Join us in changing the future of healthcare!

Continued to push the frontiers of academic and experimental research

Over 650 new studies were supported in 2021 with Empatica’s legacy research device, the E4 wristband, with over 400 academic papers published using E4-collected data throughout the year. Visit our publications page and our Research blog to see some of the highlights, and be inspired for your next research project.

Continued to serve our epilepsy community

Embrace2 remains the only FDA-cleared wrist-worn wearable in epilepsy. Thousands of people across the world are using Embrace2 to monitor their epilepsy and send alerts to their loved ones in case of a possible seizure. Hearing from our users about how it is helping them live better lives fills us with joy, and makes it a highlight not just every year, but every day.

. . .

Everyone at Empatica would like to express their gratitude for the continued support and trust you are showing in our products and work. We live in a time of striking innovation, in which technology, creativity, and science are fusing into an entity that can provide a healthier future for all of us. We feel fortunate and grateful to be part of this change, and are excited to see what 2022 will bring.

Wishing you a happy, healthy, and fulfilling new year,
The Empatica team

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Embrace is currently available only in English. Embrace is an investigational device in the USA and a medical device in the EU. If you do not see your country listed, please visit the International site.
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