AMRA Medical Secures European Medical Device Regulation Certificate for AMRA® Profiler 4, Highlighting Yet Another Regulatory Win
29.8.2024 16:55:00 EEST | Business Wire | Press release
AMRA Medical, a leading force in the development of MRI-based body composition analyses and biomarkers, is pleased to announce their EU Medical Device Regulation (MDR) certificate for the cutting-edge AMRA® Profiler 4 body composition analysis device.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240829196647/en/
AMRA® Profiler 4 provides rapid and precise body composition measurements in relation to normative data, contextualizing insights at the individual patient level, with high accuracy. (Graphic: Business Wire)
The 2017/745 (EU) MDR outlines the European regulations for medical devices and contains requirements, e.g., on the production, distribution, evaluation, and surveillance of medical devices. Manufacturers of medical devices must ensure compliance to MDR prior to bringing a medical device to the EU market. These requirements ensure that a medical device placed on the European market is both safe and effective for use by patients and providers.
The certificate comes as a successor to AMRA® Profiler 4’s 510(k) clearance by the US Food and Drug Administration (FDA), comfortably meeting the high standards for both EU and US markets in the push for increased use of AMRA’s cutting-edge body composition analysis methodologies in the clinic. Now that AMRA® Profiler 4 is CE marked, the device’s conformity with European MDR General Safety and Performance Requirements is clear. AMRA consistently demonstrates robust scientific methods and maturity in product development as they continue to take key steps in clinically translating their exciting MRI-based technologies.
AMRA® Profiler 4 provides clinicians with fat distribution, e.g., liver fat, and muscle composition biomarkers that comprise a detailed body composition profile to assist in diagnosis. Implemented right at the clinic, AMRA® Profiler 4 provides rapid and precise body composition measurements in relation to normative data, contextualizing insights at the individual patient level, with high accuracy. The AMRA biomarkers underlying this technology have proven to be useful in metabolic disease research efforts using the AMRA® Researcher service, and AMRA® Profiler 4’s recent MDR certification brings these powerful and unique biomarkers one step closer to patients everywhere.
Currently, AMRA® Profiler 4 is fully available through AMRA’s service provision in the UK, US, and Canada - with plans to roll out the product in the EU in the future following this MDR certificate milestone. If you or your organization are based in the currently cleared markets and would like to know more about bringing AMRA® Profiler 4 to your clinic, please contact info@amramedical.com.
You can learn how AMRA is using MRI-based fat distribution and muscle composition assessments to advance both research and clinical care by visiting our website, or get in touch with our knowledgeable scientists at info@amramedical.com to learn more about what AMRA can do for your trials, or for your patients.
About AMRA Medical
AMRA Medical is a health informatics and precision medicine company that is pioneering body composition analysis, providing cutting-edge solutions to advance both clinical research and patient care initiatives. AMRA's gold-standard technology delivers multiple fat and muscle biomarkers - derived simply from rapid whole-body MRI scans. AMRA is committed to driving transformative care and simplifying vital decision-making in both research and clinical care settings by offering services via their innovative platform.
Learn more about AMRA Medical’s MRI-based solutions at https://amramedical.com/solutions, or connect with our team of experts for a detailed discussion at info@amramedical.com.
Follow AMRA on LinkedIn for the latest updates in fat distribution and muscle composition assessments in disease research and precision medicine.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240829196647/en/
Contacts
Marie Börjesson
VP Brand & Marketing
marie.borjesson@amramedical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Bending Spoons completes the acquisition of Airtable4.9.2026 15:30:00 EEST | Press release
Bending Spoons S.p.A. (NASDAQ: BSP) has completed the previously announced acquisition of Airtable, the platform used by more than 500,000 organizations to reshape how teams organize data and manage critical workflows. “Airtable continues to grow because customers value its best-in-class flexibility,” said Luca Ferrari, Bending Spoons CEO and co-founder. “Teams can bring all their data, context, and AI agents together in one place, shape their workflows around their specific needs, and progressively expand their use of the platform over time. As we take the reins, our focus will be on sustaining that growth by investing heavily in Airtable’s product, customer support, and go-to-market capabilities.” “I’m proud of what the Airtable team has built and excited to see the business enter this next chapter,” said Howie Liu, co-founder of Airtable. “I’m confident Bending Spoons has the resources and long-term perspective to help Airtable continue delivering exceptional value to its customers
EQT to acquire McGill and Partners, a leading specialty (re)insurance broker for USD 2.0 billion, from Warburg Pincus4.9.2026 14:48:00 EEST | Press release
EQT and McGill and Partners are pleased to announce that EQT X ("EQT") has entered into a definitive agreement to acquire a majority stake in McGill and Partners from Warburg Pincus for USD 2.0bn. Founder and Chief Executive Officer Steve McGill will continue to lead the firm, while Chairman John Lloyd will remain actively involved. Both will remain as significant shareholders alongside the firm’s wider colleague base, while Warburg Pincus will sell its equity stake in full, marking a successful conclusion to the firms’ partnership. EQT will invest behind McGill and Partners’ ambition to drive accelerated organic growth and global expansion by continuing to attract and support specialty broking talent in key markets, invest further in technology and data capabilities, and expand the firm’s digital solutions – all while maintaining its independence, entrepreneurial culture, and colleague alignment that have been central to its success. The firm was founded in May 2019 by industry titan,
A Race Is Never Won Alone: With La Tavolata, Barilla Brings the Paddock Family Together on the Monza Grid4.9.2026 13:18:00 EEST | Press release
On Thursday evening ahead of the Formula 1® Italian Grand Prix, Barilla transformed one of the sport’s fastest and most competitive environments into a place where the Paddock Family took center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902463001/en/ La Tavolata by Barilla on the starting grid of the Monza circuit. More than two hundred people gathered around a single table: drivers, Team Principals, mechanics, engineers, strategists, safety and medical car drivers, personal trainers, tire technicians. The individuals whose collaboration, precision and trust shape every race, every decision and every performance. A nearly 100-meter table set with plates and pasta. With the first-ever Tavolata organized by Barilla and F1, people from across the Formula 1® ecosystem – including VCARB driver Yuki Tsunoda and his Race Engineer Alexandre Iliopoulos – celebrated the same principle that defines racing: exceptional pe
Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 20264.9.2026 12:30:00 EEST | Press release
Aqara, a global leader in IoT, today announced a new lineup of smart lighting products and a global community platform for smart space creators, at IFA 2026 in Berlin. The announcements reflect Aqara's ongoing vision for AI-driven spatial intelligence — spaces that understand their users and adapt to how people actually live in them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904365343/en/ Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 2026 The new lighting series — spanning indoor and outdoor use — integrates seamlessly with Aqara's existing ecosystem of sensors, switches, and hubs, bringing complete whole-space lighting scenarios and automated controls to life. The new Aqara products showcased include the Floor Lamp T1, LED Downlight T2, LED Strip T2, Outdoor String Lights H1, and Permanent Outdoor Lights H1. In addition, the company will present Aqara Builder, a platform fo
Hyper Brings its Latest Range of Power, Connectivity and MacBook Accessories to IFA 20264.9.2026 08:00:00 EEST | Press release
Messe Berlin – IFA 2026 (Hall 5.2, Stand 179) – Hyper®, an innovator of mobile accessories for Apple users, creators and mobile professionals, will showcase its latest lineup at IFA 2026, designed to make everyday mobile setups more personal, portable and productive across work, creating and travel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903870923/en/ Discover Hyper's latest MacBook accessories, power and connectivity solutions debuting at IFA 2026 Building on essential MacBook Neo accessories, the range expands across portable charging, privacy, workspace connectivity and carry solutions, led by HyperJuice Flex, Hyper’s colourful and accessible collection designed to make everyday power more portable and personal. “At IFA, we’re introducing an everyday ecosystem built around how people actually use their devices to work, create and travel,” said Gabi Iorio, Director, Global Sales and Marketing, Hyper. “From MacBo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom