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
Megaport Launches Storage, Unifying Its Automated Infrastructure Platform Alongside Compute and Network Offerings4.6.2026 01:47:00 EEST | Press release
Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport Storage, expanding its platform to deliver integrated compute, network, and storage services. Megaport Storage integrates high-performance, enterprise cloud storage directly into the Megaport Network and Latitude.sh compute platform, giving enterprises a unified foundation that covers the three key pillars of IT infrastructure: compute, network, and storage. The launch marks a culminating step in Megaport’s evolution, delivering predictable costs, seamless scalability, and direct data access wherever customers operate. “With the launch of Megaport Storage, we’re not just connecting your cloud anymore; we’re providing the foundation for it,” said Michael Reid, CEO of Megaport. “By aligning storage needs directly with workload requirements on our global ecosystem, we’re combining the performance of dedicated infrastructure with the scalability and flexibili
C.H. Robinson Launches World's First AI Technology That Continually Assesses, Improves and Operates Global Supply Chains3.6.2026 19:00:00 EEST | Press release
As the global leader in Lean AI supply chains, C.H. Robinson has built the first AI technology designed to both operate a shipper’s global supply chain and also continuously assess and improve its performance. Now serving the company’s 4PL Managed Solutions customers, a new Lean AI Engineer works in concert with the Lean AI Planner introduced last year to create one connected system that uniquely enhances a supply chain as it runs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520874794/en/ The Lean AI Engineer can assess an entire supply chain in 25 to 30 minutes and determine improvements before performance is impacted – compared to supply chain assessments that typically take up to four weeks and look backward at what has happened instead of what should happen. While the Lean AI Engineer delivers intel, the Lean AI Planner manages shipments through hundreds of interconnected AI agents and in turn feeds more data back
Leading Global Brain Science Conference OHBM 2028 to Be Held in Yokohama3.6.2026 18:00:00 EEST | Press release
Yokohama has won the bid to host the 2028 Annual Meeting of the Organization for Human Brain Mapping (OHBM 2028), one of the world’s premier international conferences in brain science, further elevating the city’s presence as a global hub for international conventions and academic exchange. The meeting will take place at PACIFICO Yokohama from June 18–22 and will mark only the second time the meeting has been held in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603787692/en/ YOKOHAMA JAPAN'S FIRST PORT OF CALL OHBM is a leading international academic society in the fields of brain imaging, neuroscience, and neurological-disease research. Its annual meeting attracts around 3,000 researchers, healthcare professionals, and industry representatives from around the world. OHBM 2028 will be organized in collaboration with the Japan Human Brain Mapping Society (JHBM, President: Yoshikazu Ugawa and Tetsuya Matsuda). The
Almarai Launches the 2026 Cycle of the World’s Largest Award for Food Security Research in Dryland Regions3.6.2026 17:31:00 EEST | Press release
The 2026 cycle of the Almarai Prize, international track of the Almarai Prize for Scientific Creativity, has officially opened, calling on leading research institutions, distinguished scientists, and global experts to nominate pioneering research that advances food security in the world’s driest regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603753914/en/ Almarai Launches the 2026 Cycle of the World’s Largest Award for Food Security Research in Dryland Regions (Photo: AETOSWire) The prize reflects Saudi Arabia’s expanding commitment to scientific innovation and to advancing solutions that tackle food security challenges in the world’s dryland regions. Almarai - a regional leader in food and agriculture - has long invested in scientific progress, sustainable farming, and long‑term food‑system resilience. As one of the world’s largest vertically integrated food companies, Almarai continues to place research and inn
Stabilizing Grids and Cutting Costs in Half: Europe Is Banking on Grid-Relevant Storage Systems3.6.2026 16:50:00 EEST | Press release
The European battery market is scaling up at record speed: According to the latest Solar+ Report from SolarPower Europe, at the end of 2025, the installed storage fleet in the EU had reached a total capacity of 40 gigawatts (GW) and a storage capacity of 77 gigawatt hours (GWh). This is an increase of over 45 percent compared to the previous year. By 2030, the study’s Solar+ scenario forecasts that capacity will quadruple to 171 GW, while storage capacity will increase eightfold to 598 GWh. As growing solar and wind capacities place increasing demands on European grids, storage systems will need to shift electricity over many hours. As a result, the average storage duration will go up from 1.9 to 3.5 hours. This represents a technological leap that underscores the need to establish more grid-relevant storage systems. Taking place in Munich from June 23–25, ees Europe will showcase how the industry is meeting this enormous demand. As Europe’s largest exhibition for batteries and energy
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