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
Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)13.7.2026 15:32:00 EEST | Press release
Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. In addition, the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T, providing regulatory recognition in the European Union and further supporting the Company's plans to advance the program globally. The FDA granted RPD Designation based on its determination that A-T is a serious and life-threatening disease that primarily affects individ
Esri Introduces ArcGIS Velocity for ArcGIS Enterprise to Power Real-Time GIS Operations13.7.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, has released for general availability ArcGIS Velocity for ArcGIS Enterprise for self-hosted deployments on Windows and Linux. This enables organizations to leverage Velocity from secure on-premises and private cloud environments. Available as software as a service (SaaS) for ArcGIS Online and now for self-hosted environments in ArcGIS Enterprise, Esri’s next-generation geospatial capability delivers real-time analytics on streaming, Internet of Things (IoT), sensor, and asset data. It helps organizations track and visualize public events, supply chains, and infrastructure to identify and respond to potential threats. ArcGIS Velocity for ArcGIS Enterprise expands cloud-native support to enterprise customers across industries in government and business that rely on firewall protection and internal security compliance. ArcGIS Velocity connects to more than 20 ready-to-use feeds for real-time data providers, including Dataminr, Samsara, Fli
HistoSonics Receives CE Mark, Unlocking Access Across Europe and Accelerating Global Commercialization of the Edison® Histotripsy Platform13.7.2026 15:00:00 EEST | Press release
HistoSonics, today announced that the company has received CE Mark approval in Europe for its Edison® System, enabling commercialization of the company’s non-invasive histotripsy technology in Europe and other markets that recognize the CE Mark. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713505048/en/ HistoSonics Edison® Histotripsy System The Edison System is a novel, non-invasive, image guided platform that is intended for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. It uses the mechanical properties of focused ultrasound, called histotripsy, to liquefy and destroy unwanted tissue and tumors in a single procedure without the need for invasive procedures or radiation, and with potentially fewer side effects than traditional therapies. CE Mark approval follows an increasing number of regulatory clearances and was supported by a growing body of clinical ev
SLB OneSubsea Awarded EPC Contract for Eni’s Baleine Phase 3 Project Offshore Côte d'Ivoire13.7.2026 15:00:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) announced today that its OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260712734539/en/ SLB OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. Under the contract, SLB OneSubsea will deliver complete subsea production systems (SPS) for 13 wells, reinforcing its role as a core technology and execution partner on one of the most strategically significant offshore developments currently underway in the region. The EPC scope includes subsea trees, umbilical, manifolds, multiphase flowmeters and control systems, along with installation, commissionin
Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer13.7.2026 13:00:00 EEST | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals. The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing a
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