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
Nebex Raises $30M Seed Round Led by GV to Build Market Infrastructure for the Global Space Economy29.6.2026 18:38:00 EEST | Press release
Nebex, the market infrastructure platform for the global space economy, announced a $30M seed investment led by GV (Google Ventures), with participation from other top-tier venture funds. The company also announced a banking relationship with J.P. Morgan. The capital raise and new banking relationship will help Nebex scale its platform and connect sovereign space programs with the founders and companies building new technologies to serve the space industry. "We built Nebex because we've seen firsthand that ambitious space founders struggle to deliver complex sovereign programs due to the lack of capital markets infrastructure that supports revenue and cashflow. This is something that exists in nearly every other industry," said Tejpaul Bhatia, CEO of Nebex. "Support from these organizations gives Nebex the additional leverage and financial infrastructure to build the global space economy at the scale it demands.” Since its inception, the space industry has run on a closed loop with a h
Medisca Enters Its Next Chapter Under Founder Antonio Dos Santos29.6.2026 17:19:00 EEST | Press release
For more than 35 years, Dos Santos has helped shape Medisca into a global leader in pharmaceutical compounding. As Chief Executive Officer, he will lead the company's long-term strategy, with a focus on expanding Medisca's global reach, investing in new areas of growth, strengthening strategic partnerships, and continuing to advance the products, services, education, and expertise that healthcare professionals rely on every day. "When I founded Medisca, my vision was to raise the standard of pharmaceutical compounding by bringing pharmaceutical-grade quality to the industry and giving healthcare professionals access to the products, knowledge, and innovation they needed to deliver better patient care," said Antonio Dos Santos, Founder and Chief Executive Officer of Medisca. "That purpose continues to guide us. As we begin this next chapter, we'll keep investing in our people, our partnerships, and the innovation that will help shape the future of Medisca and the pharmaceutical compound
The Premier Jumping League (PJL) & McCarthy Jumping Team Announce Landmark Purchase29.6.2026 16:10:00 EEST | Press release
The Premier Jumping League (PJL) today announced that seasoned trader, investor, and competitive race car driver Jason McCarthy and McCarthy Jumping League LLC acquired the first PJL team in a landmark $50 million acquisition, building on rising momentum for the highly acclaimed professional jumping league. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629512997/en/ The Premier Jumping League (PJL), photographed by Daniel Benson. The milestone investment represents an unprecedented valuation for a team in a newly established sports competition and underscores the confidence that sophisticated investors are placing in the PJL. The inaugural PJL season is scheduled to commence in April 2027. McCarthy brings extensive investment and trading experience to the League, having held leadership positions across the financial sector throughout his career. A graduate of MIT, McCarthy is the Founder and Managing Principal of a propr
InvestEco Sustainable Food Fund IV Holds a Final Close With Total Commitments of C$106M29.6.2026 16:00:00 EEST | Press release
InvestEco Capital is pleased to announce the final close of the InvestEco Sustainable Food Fund IV. This fund will continue InvestEco’s work of investing in high-growth food companies that promote health and sustainability in the food sector. The Fund closed with total commitments of C$106M, the largest InvestEco fund to date. Investors include Farm Credit Canada, Export Development Canada, Business Development Bank of Canada, Fonds de solidarité FTQ, and two Government of Canada Social Finance Fund wholesalers: Boann and Realize Capital Partners. In addition, the Fund received commitments from a number of private investors and family offices. The Fund's investments to date include Humble Snacks, Little Sesame, Mid-Day Squares and Algae Cooking Club. The Fund expects to make a further 6 - 10 investments over the next few years. InvestEco Capital, founded in 2002, is a Toronto-based venture capital firm and impact investor focused on the sustainable food sector. For more information, em
Geoswift and SKUx Announce Strategic Partnership to Develop a First-of-Its-Kind Programmable Stablecoin Commerce Network29.6.2026 15:00:00 EEST | Press release
Geoswift and SKUx announced a groundbreaking partnership to develop a next-generation programmable stablecoin commerce network. This strategic collaboration bridges digital assets, traditional finance, and real-world commerce at a global scale, representing a "one-of-one" opportunity by combining Geoswift's global infrastructure with SKUx's specialized item-level controls directly within point-of-sale (POS) systems. While enterprise stablecoin usage continues to accelerate globally, governments, enterprises, payment networks, and AI-driven commerce platforms are increasingly seeking programmable payment infrastructure that can bridge digital assets with real-world commerce. The innovation goes far beyond treasury management or even enabling consumers to spend stablecoins at retail locations. Instead, it unlocks true "programmable money" with embedded controls, rules, and purpose-driven utility —requiring both programmable settlement and programmable spending controls. Geoswift and SKUx
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