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
Smartstream Smart Agents Delivers 70% Reduction in Back-Office Investigation Time, Proving the Case for Autonomous Operations26.3.2026 11:30:00 EET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that Smart Agents - its agentic AI solution for bank back-office operations is delivering measurable, transformational impact, with pilot results showing a 70% reduction in investigation time per user, per break. As the industry accelerates toward a service as software (SaS) operating model, and allowing more work to get done from software solutions, Smartstream is embracing this approach with agentic AI. The results validate a fundamental shift in how financial institutions approach exception management. In one benchmark scenario, the manual processing of 500 exceptions, typically requiring 116 hours of team effort, was reduced to just a few hours under fully autonomous operations. This eliminates swivel-chair workflows and frees up teams to focus on risk oversight, decision making, and higher-value activities. Institutions continue to struggle with back-office w
Hytera Introduces PNC660 450MHz: New Device Certified for Power and Energy Mission-Critical Networks26.3.2026 11:00:00 EET | Press release
Hytera Communications, a leading global provider of critical communications technologies and solutions, unveiled the PNC660 450MHz MCX Smart Device – an advanced mission-critical terminal for private 450MHz LTE and 5G networks at MWC Barcelona. Combining broadband voice, video, and data services with multi-layer security, the PNC660 450MHz enables reliable communications across wide operational areas while supporting evolving mission-critical broadband needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260325346069/en/ Hytera PNC660 450MHz MCX Smart Device for mission-critical 450 MHz networks. The device has also been whitelisted by 450connect, validating its compatibility with dedicated 450MHz broadband networks and readiness for commercial deployment for power, energy providers, and other critical infrastructure. Wide-Area Coverage with Dedicated 450MHz Networks The 450MHz spectrum offers excellent propagation and buil
Infobip Supports Thousands of Startups and Scaleups Through Startup Tribe Programme26.3.2026 11:00:00 EET | Press release
Global AI-first cloud communications platform Infobip, which is celebrating its 20th anniversary this year, has supported thousands of startups and scaleups from over 120 countries in the first five years of its Startup Tribe Programme. Infobip launched its Startup Tribe Programme in May 2021 to help mission-driven startups and scaleups to build and manage their customer communications and engagement strategy and grow their business. It does this by providing access up to $60,000 in credits for Infobip’s services and its global network of advisors, investors, and accelerators. In the first five year, Infobip has provided millions in the value of products and services to its programme members. By eliminating the need to build a global communications infrastructure from the ground up, Infobip’s programme enables startups and scaleups to focus on what really matters: developing their product and scaling their business. Startup Tribe member Ilija Milovic, Co-Founder & CTO at cloud property
LTM Positioned as a Leader in ISG’s Provider Lens™ Evaluation for Oracle Cloud and Technology Ecosystem 202526.3.2026 10:58:00 EET | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, has been recognized as a Leader in multiple quadrants in the ISG Provider Lens™ Oracle Cloud and Technology Ecosystem 2025 reports for both the United States and Europe by Information Services Group (ISG), a leading global technology research and advisory firm. The ISG Provider Lens™ study evaluates leading Oracle ecosystem service providers across critical capability areas, including: Professional Services Managed Services OCI Solutions and Capabilities LTM’s positioning as a Leader across key quadrants in both regions reflects its strong Oracle ecosystem expertise, AI-led transformation approach, and proven track record in delivering large-scale enterprise cloud modernization programs. In its 2025 study, ISG highlights that the Oracle ecosystem is undergoing a fundamental shift toward AI-native architectures, multicloud-by-design strategies, and asset-based delivery models, with sovereignty and regulatory compli
Bureau Veritas Strengthens Global Sustainable Finance Capabilities with Expanded Climate Bonds Approved Verifier Status26.3.2026 09:30:00 EET | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), is pleased to announce the expansion of its geographical scope as an Approved Verifier under the Climate Bonds Standard and Certification Scheme. Additional offices in China, Japan, India, and France are now formally listed in the Climate Bonds Verifiers Directory. This expansion builds on Bureau Veritas’ established role since the approval of its Brazilian office in 2020, further enhancing its ability to support issuers with high-quality, independent verification services across key markets. “Our expanded presence as an Approved Verifier under the Climate Bonds Standard reinforces Bureau Veritas’ commitment to advancing credible, high‑integrity sustainable finance”, said Marc Roussel, Executive Vice President, Urbanization and Assurance at Bureau Veritas. “With verifier capabilities available across key markets, we continue to deliver local expertise with global assurance standards; boosting mark
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