Latest news with #EUMedicalDeviceRegulation
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
14-03-2025
- Business
- Yahoo
AI-Powered Healthcare: How ADLINK's Medical Innovations at HIMSS 2025 Are Transforming Patient Care
Celebrating 30 Years of Innovation Excellence with Advanced OEM Solutions for Healthcare Summary: Successful Showcase: ADLINK's latest AI-driven medical solutions attracted strong industry interest at HIMSS 2025 Engagement & Collaboration: Engaged with healthcare leaders, medical device manufacturers, and key industry partners Technology Highlights: Demonstrated advanced medically certified UHD surgical monitors, NVIDIA IGX-powered computing, and high-performance medical box PCs Long-Term Value: Reinforced commitment to extended lifecycle support, regulatory compliance, and strategic partnerships LAS VEGAS, March 14, 2025 /PRNewswire/ -- As healthcare companies continue to seek cutting-edge solutions to enhance patient care, ADLINK Technology Inc. showcased its latest AI-powered medical innovations at HIMSS 2025, providing real-world applications that help medical professionals improve diagnostics, streamline workflows, and deliver better outcomes. With a focus on solving critical industry challenges, ADLINK's advanced OEM solutions are accelerating the adoption of AI in healthcare, driving efficiency, and enabling new treatment possibilities. Addressing Healthcare's Biggest Challenges with AI At HIMSS 2025, ADLINK demonstrated how its AI-driven technology is making a difference in real-world medical environments. From precision imaging in surgery to real-time AI inferencing for diagnostics, ADLINK's solutions are helping healthcare professionals optimize care delivery and improve decision-making. Key innovations on display included: Medically Certified UHD Surgical Monitors: Delivered exceptional image reproduction and color accuracy for enhanced surgical precision. Versatile All-in-One Medical Panel PCs: Designed for safety and compliance, meeting stringent EU Medical Device Regulation (MDR) standards. MLB-IGX Medical Box PC: Leveraging NVIDIA IGX technology, providing ultra-fast, low-latency performance ideal for AI-driven real-time inferencing. High-Performance Medical Box PCs: Engineered for advanced image processing, real-time data integration, and AI-powered surgical navigation. Advanced GPU Solutions: Featuring NVIDIA RTX 2000 and RTX 5000 Lovelace Architecture for high-performance medical imaging applications. Enabling Healthcare Innovation Through AI & Imaging ADLINK's focus at HIMSS 2025 was on demonstrating tangible benefits for healthcare providers and device manufacturers. The company's FPGA-powered image processing and custom DICOM calibration are advancing imaging technology, ensuring precise diagnostics and faster patient assessments. Scalable embedded GPUs provide AI-driven insights, helping clinicians detect anomalies and make more informed decisions. "Our technology is designed to solve real-world challenges in healthcare," said Jacky Lin, VP of Business Development at ADLINK Technology. "By leveraging AI and advanced imaging, we are enabling medical professionals to improve accuracy, efficiency, and patient outcomes." Collaborating for a Smarter Future in Healthcare Throughout HIMSS 2025, ADLINK engaged with leading medical device manufacturers and healthcare organizations to discuss the future of AI-driven healthcare solutions. The company's strategic partnerships with Intel, NVIDIA, AMD, and NXP are fostering new developments in AI-powered diagnostics, automation, and patient care. These collaborations ensure that ADLINK's technology aligns with industry needs and regulatory requirements. Beyond HIMSS 2025: The Future of AI in Healthcare The strong reception at HIMSS 2025 underscores the growing demand for AI-integrated medical technology. ADLINK remains committed to partnering with healthcare innovators to deliver next-generation solutions that optimize workflows, enhance precision, and improve patient care. With an emphasis on long-term reliability and compliance, ADLINK's healthcare-focused solutions will continue to drive transformation in the industry. For more information about ADLINK's healthcare solutions, visit ADLINK Healthcare. About ADLINK Technology ADLINK Technology Inc. is a global leader in edge computing. Our mission is to affect positive change in society and industry by connecting people, places and things with AI. The company offerings include robust boards, real-time data acquisition solutions and application enablement for AIoT. ADLINK serves customers in many industries, including healthcare, manufacturing, communications, transportation, defense, and aerospace. ADLINK is a Premier Member of the Intel® Internet of Things Solutions Alliance, a partner of NVIDIA, and a contributor to standards initiatives such as Eclipse, OCP, OMG and ROS2 TSC. ADLINK is ISO-9001, ISO-14001, ISO-13485 and TL9000 certified and is publicly traded on TAIEX (Stock Code: 6166). Learn more at View original content to download multimedia: SOURCE ADLINK Technology
Associated Press
14-03-2025
- Business
- Associated Press
AI-Powered Healthcare: How ADLINK's Medical Innovations at HIMSS 2025 Are Transforming Patient Care
Celebrating 30 Years of Innovation Excellence with Advanced OEM Solutions for Healthcare Summary: Successful Showcase: ADLINK's latest AI-driven medical solutions attracted strong industry interest at HIMSS 2025 Engagement & Collaboration: Engaged with healthcare leaders, medical device manufacturers, and key industry partners Technology Highlights: Demonstrated advanced medically certified UHD surgical monitors, NVIDIA IGX-powered computing, and high-performance medical box PCs Long-Term Value: Reinforced commitment to extended lifecycle support, regulatory compliance, and strategic partnerships LAS VEGAS, March 14, 2025 /PRNewswire/ -- As healthcare companies continue to seek cutting-edge solutions to enhance patient care, ADLINK Technology Inc. showcased its latest AI-powered medical innovations at HIMSS 2025, providing real-world applications that help medical professionals improve diagnostics, streamline workflows, and deliver better outcomes. With a focus on solving critical industry challenges, ADLINK's advanced OEM solutions are accelerating the adoption of AI in healthcare, driving efficiency, and enabling new treatment possibilities. Addressing Healthcare's Biggest Challenges with AI At HIMSS 2025, ADLINK demonstrated how its AI-driven technology is making a difference in real-world medical environments. From precision imaging in surgery to real-time AI inferencing for diagnostics, ADLINK's solutions are helping healthcare professionals optimize care delivery and improve decision-making. Key innovations on display included: Medically Certified UHD Surgical Monitors: Delivered exceptional image reproduction and color accuracy for enhanced surgical precision. Versatile All-in-One Medical Panel PCs: Designed for safety and compliance, meeting stringent EU Medical Device Regulation (MDR) standards. MLB-IGX Medical Box PC: Leveraging NVIDIA IGX technology, providing ultra-fast, low-latency performance ideal for AI-driven real-time inferencing. High-Performance Medical Box PCs: Engineered for advanced image processing, real-time data integration, and AI-powered surgical navigation. Advanced GPU Solutions: Featuring NVIDIA RTX 2000 and RTX 5000 Lovelace Architecture for high-performance medical imaging applications. Enabling Healthcare Innovation Through AI & Imaging ADLINK's focus at HIMSS 2025 was on demonstrating tangible benefits for healthcare providers and device manufacturers. The company's FPGA-powered image processing and custom DICOM calibration are advancing imaging technology, ensuring precise diagnostics and faster patient assessments. Scalable embedded GPUs provide AI-driven insights, helping clinicians detect anomalies and make more informed decisions. 'Our technology is designed to solve real-world challenges in healthcare,' said Jacky Lin, VP of Business Development at ADLINK Technology. 'By leveraging AI and advanced imaging, we are enabling medical professionals to improve accuracy, efficiency, and patient outcomes.' Collaborating for a Smarter Future in Healthcare Throughout HIMSS 2025, ADLINK engaged with leading medical device manufacturers and healthcare organizations to discuss the future of AI-driven healthcare solutions. The company's strategic partnerships with Intel, NVIDIA, AMD, and NXP are fostering new developments in AI-powered diagnostics, automation, and patient care. These collaborations ensure that ADLINK's technology aligns with industry needs and regulatory requirements. Beyond HIMSS 2025: The Future of AI in Healthcare The strong reception at HIMSS 2025 underscores the growing demand for AI-integrated medical technology. ADLINK remains committed to partnering with healthcare innovators to deliver next-generation solutions that optimize workflows, enhance precision, and improve patient care. With an emphasis on long-term reliability and compliance, ADLINK's healthcare-focused solutions will continue to drive transformation in the industry. For more information about ADLINK's healthcare solutions, visit ADLINK Healthcare. About ADLINK Technology ADLINK Technology Inc. is a global leader in edge computing. Our mission is to affect positive change in society and industry by connecting people, places and things with AI. The company offerings include robust boards, real-time data acquisition solutions and application enablement for AIoT. ADLINK serves customers in many industries, including healthcare, manufacturing, communications, transportation, defense, and aerospace. ADLINK is a Premier Member of the Intel® Internet of Things Solutions Alliance, a partner of NVIDIA, and a contributor to standards initiatives such as Eclipse, OCP, OMG and ROS2 TSC. ADLINK is ISO-9001, ISO-14001, ISO-13485 and TL9000 certified and is publicly traded on TAIEX (Stock Code: 6166).
