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
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 16:30:00 EEST | Press release
Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer sessions, hands-on experiences and peer networking with the continent’s top CHROs and HRIT decision-makers, guests can participate in discussion
European Firms Struggle to Keep Pace with Growing DSAR Demands, New Reveal Study Finds6.10.2026 16:00:00 EEST | Press release
New research published today byReveal, the provider of integrated AI-native platforms spanning the dispute resolution lifecycle, found that large European organisations complete fewer than half of data subject access requests (DSARs) within the one-month deadline required under the General Data Protection Regulation (GDPR), a shortfall the study ties directly to a near-universal absence of purpose-built technology. Nearly nine in 10 organisations still run DSARs on manual or general-purpose workflows, with no dedicated tooling in place. The report, based on a survey of 213 legal and privacy professionals at large European enterprises, is the first of its kind to benchmark how organisations across the region are managing DSAR compliance at scale. The findings expose structural inconsistencies between how organisations perceive their DSAR processes and how those processes perform. Ninety percent of respondents said they are confident their process would withstand scrutiny from an Informa
Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets6.10.2026 16:00:00 EEST | Press release
Rochester Electronics today announced the launch of fully enabled e-commerce capabilities across its regional websites, allowing customers in key global markets to search for, source, and purchase authorized semiconductors in their local language. While Rochester's regional sites previously offered localized content and product information, they now support a complete end-to-end purchasing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006914131/en/ Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets The newly upgraded platforms are now live in Portuguese (Brazil), Spanish (Mexico), French, German, Italian, and Polish, complementing Rochester’s existing full e-commerce platforms in English, Chinese, Japanese, and Korean (South Korea). Customers can now complete transactions directly through their local sites, simplifying sourcing, improving efficiency, and reducing process
Xsolla Shows Brand Owners How to Create Value for Video Players at Brand Licensing Europe With Rewarded Marketing6.10.2026 16:00:00 EEST | Press release
Xsolla, a global commerce company, today announced it will be at Brand Licensing Europe 2026 at ExCeL London, October 6 to 8, to show brand owners how to engage with video game players by creating quest-based programs and value new users actually value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006443167/en/ Graphic: Xsolla Video games are one of the largest categories of entertainment spending in the world, yet most brands still treat the category as an experiment: a one-off promotional stunt or a single media buy, not a lasting engagement program. The traditional formats brands default to were never built for players. Interstitial pop-ups disrupt gameplay, banner ads go unnoticed, and in-game activations remain cumbersome and expensive to execute. The idea is already proven in games, where players have purchased, collected, and valued digital items for years. The relationship between players and games is built on t
New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support6.10.2026 16:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced findings from the 2026 IT Virtualization Survey – What’s Next for VMware Users, a new global survey of nearly 300 VMware user organizations conducted by Unisphere Research on behalf of Rimini Street. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006014490/en/ New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support Cost Cited as the Number One Factor in Seeking Alternative VMware Solutions Key Findings: 90% of respondents said they are considering alternatives to VMware due to higher licensing costs, while 54% cited the end of perpetual license support as another reason to evaluate other options. The research shows that cost remains the leading driver of virtuali
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