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
Merz Therapeutics Announces Completion of Recruitment in Two Phase III Trials Investigating XEOMIN ® (incobotulinumtoxinA) for Migraine Prevention15.10.2026 09:00:00 EEST | Press release
Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, today announced the completion of patient recruitment in two global Phase III clinical trials, MINT-E (NCT07018700) and MINT-C (NCT07018713), evaluating the efficacy and safety of XEOMIN® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. The trials recruited approximately 1800 adults across 109 study sites in North America and Europe. Migraine affects around 1.1 billion people worldwide, posing a significant burden on patients, society and healthcare systems.1 Both trials are evaluating the change in monthly migraine days from baseline to Month 6 as the primary endpoint. Secondary endpoints include changes in monthly headache days, acute medication days and migraine frequency during two-week periods at the end of each injection cycle. “Achieving patient recruitment for both MINT-C and MINT-E six months ahead of plan is an important milestone for our XEOMIN® migraine preven
Tourism Malaysia and Alipay+ Partner to Accelerate Malaysia’s Digital Tourism Transformation15.10.2026 08:10:00 EEST | Press release
Tourism Malaysia and Alipay+, the unified wallet gateway of Ant International, today signed a Memorandum of Understanding (MoU) to accelerate cross-border commerce and digitalise merchant engagement across Malaysia's tourism economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014035900/en/ (From left) Mr Mohd Akbal Setia (Head of VM2026 Secretariat and Senior Director, Advertising & Digital Tourism); Mr Mohd Amirul Rizal Abdul Rahim (Director General, Tourism Malaysia); Mr Danny Chung (General Manager of Alipay+ Global Growth Center and Vice President of Ant International); Mr Michael Guo, Alipay+ General Manager of SEA, South Asia and ANZ, Ant International) As Malaysia welcomes visitors for Visit Malaysia 2026–2027 (VM2026–2027), this partnership merges Tourism Malaysia’s destination marketing with Alipay+’s global wallet ecosystem and AI capabilities. It aims to create a highly intelligent digital journey, connecti
PeDRA 2026: Nemolizumab Phase II Data Show Long-Term Symptom Relief for Children Aged 2 to 11 Years With Moderate-to-Severe Atopic Dermatitis15.10.2026 08:00:00 EEST | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced new phase II data showing that nemolizumab provided meaningful improvements in itch, sleep disturbance, and quality of life in children aged 2 to 11 years with moderate-to-severe atopic dermatitis, sustained through Week 52.1 The results will be presented at The Pediatric Dermatology Research Alliance (PeDRA) Annual Conference. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014705800/en/ Up to 25% of children are affected by atopic dermatitis - the most common inflammatory skin disorder in this population - and around one-third of these children have moderate-to-severe disease.11,12 Atopic dermatitis creates a high burden for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school, and social confidence.2-8 Despite the high prevalence and significant burden, treatment options are
Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 115.10.2026 03:30:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK)announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1. “We’re excited at the potential to fundamentally change how NT1 is managed across Japan and China,” said Giles Platford, president, International, Takeda. “We’ve heard from patients how ORZEYFUL has improved their daily functioning and quality of life, enormously meaningful outcomes for a condition known to impact many aspects of a person’s life, including work, education and social interactions.”1,2,3,4,5 NT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disr
Celltrion to Spotlight Subcutaneous (SC) Infliximab (Remsima™ SC) and Broader IBD Portfolio at UEG Week 202615.10.2026 03:10:00 EEST | Press release
Celltrion, Inc. (KRX:068270) announced its participation in United European Gastroenterology (UEG) Week 2026, in Barcelona, Spain (Oct. 17-20), highlighting its inflammatory bowel disease (IBD) treatment portfolio, led by Remsima™ SC (subcutaneous infliximab). Celltrion will showcase its comprehensive infliximab portfolio, comprising Remsima™ intravenous (IV) and subcutaneous (SC) formulations, as well as the Remsima™ IV liquid formulation launched in Europe earlier this year.1 Additionally, the company will highlight its broader IBD portfolio, including SteQeyma™ (ustekinumab) and Yuflyma™ (adalimumab), reflecting its continued efforts to expand treatment options for patients with IBD.2,3 On October 18, Celltrion will host a symposium titled "Navigating the Treatment Journey with Subcutaneous Infliximab Across Clinical Scenarios," Chaired by Professor Peter M. Irving of King's College London, UK, a leading IBD expert. Celltrion will also host two MTE sessions at its booth. In the firs
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