Latest news with #Empatica
Business Wire
25-06-2025
- Health
- Business Wire
Empatica Unveils EmbraceMini: The World's Smallest Actigraphy Wearable for Clinical Trials
BOSTON--(BUSINESS WIRE)-- Empatica, a pioneer in digital biomarker development and patient monitoring using wearables and AI, today unveiled EmbraceMini, its revolutionary new wearable for clinical trials. We've created a wearable that combines the reliability of a medical device with the accessibility of a design accessory, something previously missing from the market. - Matteo Lai, Empatica's CEO and Co-founder Share EmbraceMini is an ultra-compact health monitoring device, focused on delivering exceptional wearability and high-quality data without compromising sponsor or participant needs. With its incredibly small footprint and refined looks, EmbraceMini offers effortless, seamless and non-invasive activity data collection while prioritizing the patient experience at all times. It wirelessly transmits sensor data to the FDA-cleared Empatica Health Monitoring Platform, enabling the continuous analysis and extraction of precise digital biomarkers from clinical trial participants while boosting compliance. 'We've created a wearable that combines the reliability of a medical device with the accessibility of a design accessory, something previously missing from the market,' said Empatica's CTO and Co-founder, Simone Tognetti. 'Most devices adopted in clinical trials today are too bulky, or just not fit for purpose. Wearability is crucial for the success of the study, so our goal with EmbraceMini was to make a compact, beautiful wearable that offers the same data quality and range as EmbracePlus, without 'competing' with people's favorite watches or accessories for room on their wrist.' At just 12mm thick and 14mm wide, EmbraceMini is the smallest wristworn actigraphy device for clinical research in the world – the size of an AA battery. It is purpose-made for studies that track sleep and movement, with a long battery life that can achieve at least 7 days of continuous data collection. EmbraceMini can passively monitor over 200 digital measures, including digital biomarkers across physical activity, sleep, gait, and light exposure. These can serve a key role as digital endpoints in trials on sleep disorders, movement disorders, obesity, depression, pain, and more. In addition, EmbraceMini can collect raw sensor data, providing more transparency and flexibility in how information can be processed. Thanks to Empatica's modular approach, EmbraceMini can be worn on the wrist, leg, around the waist, or the ankle. Empatica allows simultaneous data collection using multiple devices, so researchers can combine data from Empatica's flagship wearable EmbracePlus (including cardiorespiratory measures) and EmbraceMini, or use two EmbraceMini units worn at different body locations for richer insights. Besides working seamlessly with Empatica's software, EmbraceMini can also be integrated into existing Clinical Trial Management Systems using a Cloud API. FDA clearance for EmbraceMini is expected in late 2025. If you are interested in learning more about the device and to request a demo, visit or write to Empatica at research@ Empatica Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's FDA-cleared platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and the NASA-funded TRISH.
Yahoo
28-05-2025
- Business
- Yahoo
Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe
BOSTON, May 28, 2025--(BUSINESS WIRE)--Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor, its pioneering epilepsy monitoring solution, is now a CE-certified device according to EU Medical Device Regulation 2017/745 and available in Europe. EpiMonitor is a game-changing, medical-grade wearable and app combination that revolutionizes epilepsy care, providing seizure detection and alerting alongside continuous health monitoring capabilities also used in clinical research settings. EpiMonitor comprises the sophisticated EmbracePlus watch and a companion smartphone app. EpiMonitor's algorithm continuously analyzes user data, looking for patterns that may resemble a generalized tonic-clonic seizure, and sends automated alerts to caregivers with scientifically proven 98% accuracy. EpiMonitor also offers a detailed sleep, activity, and seizure diary, providing people with epilepsy and their doctors with important information to make empowered decisions on their health journey. EpiMonitor is now available in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland. The EpiMonitor app is also available in all local languages for a seamless experience for its users. "EpiMonitor's availability in Europe is a great milestone for the epilepsy community," said Simone Tognetti, Empatica's CTO & Co-founder. "Our goal is to continue bringing technology that improves lives to more people around the world. EpiMonitor is the world's only non-invasive, medical-grade wearable for night and day epilepsy monitoring, and our rigorous engineering methods and quality processes guarantee unmatched safety and accuracy. With EpiMonitor, we have taken the best of our previous wearables and amplified it in a solution that uses our most innovative and powerful technology, alongside algorithms that provide detailed and meaningful health insights. We didn't want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world." Key features of EpiMonitor include: Fully medical-grade technology consisting of a wearable and app Automatic generalized tonic-clonic seizure detection and alerts to caregivers (98% accuracy; low False Alarm Rate) Ability for users to send self-triggered alerts to caregivers Up to 7 days of battery life A user-friendly mobile app with a detailed, automated diary Daily sleep and activity tracking through Empatica's algorithms Detailed reports that can be exported and shared with a doctor High accessibility with app translations in 8 languages Compatibility with iOS and Android smartphones Empatica has been the market leader in providing the world's only medical watches for people living with epilepsy for nearly a decade. Epilepsy affects 6 million people in Europe, with approximately 15% of those being children. Studies indicate that up to 40% of epilepsy cases are difficult to treat, and a third of people with epilepsy are refractory to current medications. Sudden Unexpected Death in Epilepsy (SUDEP) is the number one cause of epilepsy-related deaths in people with pharmacoresistant epilepsy. Most SUDEP deaths occur when a generalized tonic-clonic seizure occurs during sleep. EpiMonitor can be purchased directly from the Empatica website. To learn more visit Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. In 2018, Empatica's Embrace wearable received FDA clearance for seizure monitoring, making it the world's first epilepsy watch to be cleared by the FDA. Its successor, EpiMonitor, launched in the US in 2024 after receiving FDA clearance. Empatica's flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA. View source version on Contacts Marianna Xenophontospress@
Business Wire
28-05-2025
- Health
- Business Wire
Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe
BOSTON--(BUSINESS WIRE)--Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor, its pioneering epilepsy monitoring solution, is now a CE-certified device according to EU Medical Device Regulation 2017/745 and available in Europe. EpiMonitor is a game-changing, medical-grade wearable and app combination that revolutionizes epilepsy care, providing seizure detection and alerting alongside continuous health monitoring capabilities also used in clinical research settings. "We didn't want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world." Simone Tognetti, Empatica's CTO & Co-founder Share EpiMonitor comprises the sophisticated EmbracePlus watch and a companion smartphone app. EpiMonitor's algorithm continuously analyzes user data, looking for patterns that may resemble a generalized tonic-clonic seizure, and sends automated alerts to caregivers with scientifically proven 98% accuracy. EpiMonitor also offers a detailed sleep, activity, and seizure diary, providing people with epilepsy and their doctors with important information to make empowered decisions on their health journey. EpiMonitor is now available in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland. The EpiMonitor app is also available in all local languages for a seamless experience for its users. 'EpiMonitor's availability in Europe is a great milestone for the epilepsy community,' said Simone Tognetti, Empatica's CTO & Co-founder. 'Our goal is to continue bringing technology that improves lives to more people around the world. EpiMonitor is the world's only non-invasive, medical-grade wearable for night and day epilepsy monitoring, and our rigorous engineering methods and quality processes guarantee unmatched safety and accuracy. With EpiMonitor, we have taken the best of our previous wearables and amplified it in a solution that uses our most innovative and powerful technology, alongside algorithms that provide detailed and meaningful health insights. We didn't want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world.' Key features of EpiMonitor include: Fully medical-grade technology consisting of a wearable and app Automatic generalized tonic-clonic seizure detection and alerts to caregivers (98% accuracy; low False Alarm Rate) Ability for users to send self-triggered alerts to caregivers Up to 7 days of battery life A user-friendly mobile app with a detailed, automated diary Daily sleep and activity tracking through Empatica's algorithms Detailed reports that can be exported and shared with a doctor High accessibility with app translations in 8 languages Compatibility with iOS and Android smartphones Empatica has been the market leader in providing the world's only medical watches for people living with epilepsy for nearly a decade. Epilepsy affects 6 million people in Europe, with approximately 15% of those being children. Studies indicate that up to 40% of epilepsy cases are difficult to treat, and a third of people with epilepsy are refractory to current medications. Sudden Unexpected Death in Epilepsy (SUDEP) is the number one cause of epilepsy-related deaths in people with pharmacoresistant epilepsy. Most SUDEP deaths occur when a generalized tonic-clonic seizure occurs during sleep. EpiMonitor can be purchased directly from the Empatica website. To learn more visit Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. In 2018, Empatica's Embrace wearable received FDA clearance for seizure monitoring, making it the world's first epilepsy watch to be cleared by the FDA. Its successor, EpiMonitor, launched in the US in 2024 after receiving FDA clearance. Empatica's flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA.
Yahoo
28-05-2025
- Business
- Yahoo
Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe
BOSTON, May 28, 2025--(BUSINESS WIRE)--Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor, its pioneering epilepsy monitoring solution, is now a CE-certified device according to EU Medical Device Regulation 2017/745 and available in Europe. EpiMonitor is a game-changing, medical-grade wearable and app combination that revolutionizes epilepsy care, providing seizure detection and alerting alongside continuous health monitoring capabilities also used in clinical research settings. EpiMonitor comprises the sophisticated EmbracePlus watch and a companion smartphone app. EpiMonitor's algorithm continuously analyzes user data, looking for patterns that may resemble a generalized tonic-clonic seizure, and sends automated alerts to caregivers with scientifically proven 98% accuracy. EpiMonitor also offers a detailed sleep, activity, and seizure diary, providing people with epilepsy and their doctors with important information to make empowered decisions on their health journey. EpiMonitor is now available in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland. The EpiMonitor app is also available in all local languages for a seamless experience for its users. "EpiMonitor's availability in Europe is a great milestone for the epilepsy community," said Simone Tognetti, Empatica's CTO & Co-founder. "Our goal is to continue bringing technology that improves lives to more people around the world. EpiMonitor is the world's only non-invasive, medical-grade wearable for night and day epilepsy monitoring, and our rigorous engineering methods and quality processes guarantee unmatched safety and accuracy. With EpiMonitor, we have taken the best of our previous wearables and amplified it in a solution that uses our most innovative and powerful technology, alongside algorithms that provide detailed and meaningful health insights. We didn't want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world." Key features of EpiMonitor include: Fully medical-grade technology consisting of a wearable and app Automatic generalized tonic-clonic seizure detection and alerts to caregivers (98% accuracy; low False Alarm Rate) Ability for users to send self-triggered alerts to caregivers Up to 7 days of battery life A user-friendly mobile app with a detailed, automated diary Daily sleep and activity tracking through Empatica's algorithms Detailed reports that can be exported and shared with a doctor High accessibility with app translations in 8 languages Compatibility with iOS and Android smartphones Empatica has been the market leader in providing the world's only medical watches for people living with epilepsy for nearly a decade. Epilepsy affects 6 million people in Europe, with approximately 15% of those being children. Studies indicate that up to 40% of epilepsy cases are difficult to treat, and a third of people with epilepsy are refractory to current medications. Sudden Unexpected Death in Epilepsy (SUDEP) is the number one cause of epilepsy-related deaths in people with pharmacoresistant epilepsy. Most SUDEP deaths occur when a generalized tonic-clonic seizure occurs during sleep. EpiMonitor can be purchased directly from the Empatica website. To learn more visit Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. In 2018, Empatica's Embrace wearable received FDA clearance for seizure monitoring, making it the world's first epilepsy watch to be cleared by the FDA. Its successor, EpiMonitor, launched in the US in 2024 after receiving FDA clearance. Empatica's flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA. View source version on Contacts Marianna Xenophontospress@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
