Qure.ai Awarded EU MDR Certification for Its AI solutions
22.2.2023 14:28:00 EET | Business Wire | Press release
Qure.ai, a leading provider of artificial intelligence (AI) software for medical imaging, today announced that its solutions were awarded the CE Class IIb certification for medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
Qure.ai now offers one of the most comprehensive, certified portfolios of AI-based detection devices for radiology in the EU, spanning over 31 countries. Qure’s AI helps detect abnormalities from multiple radiology modalities including Chest X-rays, Chest CT, Head CT, and Musculoskeletal X-rays. These medical devices are cutting-edge AI software that assist radiologists in interpreting radiological scans in different healthcare settings.
Concerning the newest milestone, Prashant Warier, Co-founder and CEO of Qure.ai, said, “The EU MDR certification demonstrates our commitment to meeting the highest standards of safety and effectiveness of our products. Qure's products have undergone extensive validation and have been actively deployed globally at more than 1000 sites across 75+. Receiving EU MDR certification is a testament to the continued quality of our solutions, and it further strengthens our position as a trusted provider of AI software. The EU MDR certification will allow us to expand our reach in the EU market and enable better patient outcomes with our imaging AI solutions. We will continue to work closely with regulatory bodies to ensure compliance with the EU MDR and other relevant regulations."
EU MDR certification process is rigorous and comprehensive, ensuring that medical devices meet high safety, performance, and quality standards. Qure products are validated in 71 countries.
"Last year, Erasmus MC and Qure.ai launched an AI Innovation Centre for Medical Imaging. This innovation center will evaluate Qure's solutions for their robustness and ability to improve patient outcomes. Gauging the performance of AI solutions in different population cohorts will help create evidence for their adoption in care workflows as clinical decision support tools," says Dr. Jacob J. Visser, radiologist, chief medical information officer, and assistant-professor Value-based imaging AI at Erasmus MC. "This will give detailed insights into their use cases in disease-specific workflows like lung cancer, ER, stroke, etc., and assess the added value for patient care," he added.
The MDR certification recognizes the safety, performance, and quality of Qure.ai's AI software and confirms its compliance with EU medical device regulations. In addition, the certification assures healthcare providers and patients that Qure.ai's AI software has undergone extensive evaluation and is safe, effective, and reliable across global markets.
About Qure.ai
Qure.ai is a breakthrough Artificial Intelligence (AI) solution provider disrupting the radiology status quo by enhancing imaging accuracy and improving health outcomes with the assistance of machine-supported tools. Qure.ai taps deep learning technology to provide automated interpretation of radiology examinations like X-rays, CTs, Ultrasounds and MRI scans for time and resource-strapped medical imaging professionals—enabling faster diagnosis and speed to treatment. Qure.ai is helping to make healthcare more accessible and affordable to patients worldwide.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230222005474/en/
Contact information
Media Queries
Amrutha Joseph | Amrutha.joseph@qure.ai | +91 8281244284
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Grindr for Equality Commits to Connecting 10M to HIV Prevention by 202827.7.2026 17:31:00 EEST | Press release
Today at the 2026 International AIDS Conference, Grindr for Equality committed to connecting ten million LGBTQ+ people to HIV prevention by 2028, leveraging its platform reach to advance the global effort to end HIV by 2030. The commitment is rooted in Closing the Gap, a new Grindr for Equality report drawing on survey data from Grindr users across ten countries. The central finding is consistent across countries: people know about PrEP but they are not taking it. The barrier is access and the funding that existed to address it is disappearing. "Connecting people is what Grindr does at a scale and in communities that traditional public health systems don't effectively reach," said George Arison, CEO and Chairman of Grindr (NYSE: GRND). "The global HIV response is losing critical funding at the exact moment we should be accelerating to end HIV by 2030. Grindr has the reach and the responsibility to help close that access gap -- and we are proud to step up." Fifteen million people use Gr
InterSystems Launches Data Studio AI Assistant to Accelerate Enterprise Data Exploration and Insights27.7.2026 17:00:00 EEST | Press release
InterSystems, a creative data technology provider powering some of the world's most important applications, today announced the general availability of InterSystems Data Studio™ AI Assistant, a new generative AI-powered extension for InterSystems Data Studio that helps organizations more easily understand, navigate, query, and visualize data through natural language interactions. As organizations move from AI experimentation to production deployments, many are discovering that the greatest challenge is not the AI model itself, but providing AI systems with access to trusted, current, and business-ready information. Enterprise data is often fragmented across applications, databases, cloud services, files, data warehouses, and departmental silos, making it difficult for users and AI systems to generate reliable insights. “Organizations are increasingly looking for ways to turn their data into actionable intelligence without adding complexity,” said Scott Gnau, Senior Vice President, Data
PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities27.7.2026 15:00:00 EEST | Press release
Philip Morris International Inc.’s (PMI) (NYSE: PM) U.S. businesses (PMI U.S.) today celebrated the opening of its Aurora, Colorado manufacturing campus, a landmark investment representing total capital expenditures of $1.2 billion from 2024-2028. The campus expands the company’s domestic manufacturing capabilities, strengthens supply chain resilience, and positions Aurora as a strategic production and export hub supporting future growth. The site began commercial production in July 2026 and produces ZYN nicotine pouches, joining PMI U.S.’s growing modern nicotine manufacturing network, which includes operations in Owensboro, Kentucky, and Wilson, North Carolina. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727514086/en/ PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities Situated on a 148-acre site, the approximately 780,000-square-foot campus is PMI’s first greenfield ma
Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million27.7.2026 14:20:00 EEST | Press release
Tecnotree, a global leader in AI-native Digital Business Support Systems (BSS) and digital platform solutions, today announced it has secured new digital transformation contracts across Latin America with a combined value of USD 8.8 million, reinforcing the company’s continued commercial momentum and expanding its presence across one of its key strategic growth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727931342/en/ Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million Across the engagements, Tecnotree will deploy its AI-native digital platform and B2B Marketplace for enterprises to simplify customer and business operations through intelligent digital engagement, real-time monetization, digital commerce and partner ecosystem management and AI driven marketing and experience management. By providing a unified digital foundation, the platform enables communications
Pure Lithium Corporation Appoints Mercedes-Benz Battery Veteran Dr. Tobias Glossmann as Chief Product Officer27.7.2026 14:00:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery company and developer of the patented Brine to Battery™ technology, today announced the appointment of Dr. Tobias Glossmann as Chief Product Officer. In this role, Dr. Glossmann will lead product and technology strategy, guiding the translation of Pure Lithium’s battery science into engineered products and directing the company’s product engineering efforts. Dr. Glossmann joins Pure Lithium after a 25-year career across Mercedes-Benz companies, most recently serving as Principal Systems Engineer at Mercedes-Benz Research & Development North America. His work spanned advanced battery technology development, from materials through complete battery systems, and he held companywide responsibility for high voltage safety. His career began in 2001 with battery systems development at DaimlerChrysler in Ulm, Germany, and later in Michigan, giving him more than two decades of experience across cell chemistry
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