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
Incyte Announces Positive CHMP Opinion for Opzelura ® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 14:30:00 EEST | Press release
Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP o
Datroway ® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 14:00:00 EEST | Press release
Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02phase 3 trial, which werepresented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast02, Datroway demonstrated a
DAYBU ® (trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 13:49:00 EEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating condition," said Catherine Owen Adams, Acadia’s Chief Executive Officer. “Our commitment is to make a meaningful difference in the lives of patients, caregivers, and the wider Rett com
HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 12:18:00 EEST | Press release
HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi
Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 11:28:00 EEST | Press release
Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di
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