Health-Tech AI Gets CE Mark for Diagnostic Support in Clinical Settings
Regulatory clearance enables clinical deployment across EU markets for AI-powered decision support tool that reduces diagnostic interpretation time by up to 40%
AMSTERDAM, Netherlands – November 28, 2025 – MedVision AI, a clinical-stage health technology company developing artificial intelligence solutions for medical imaging, today announced it has received CE Mark approval under the European Union’s Medical Device Regulation (MDR 2017/745) for its flagship product, MedVision Dx Pro. The certification allows immediate commercialization and clinical use of the AI-powered diagnostic support platform across all 27 EU member states and the UK.
The CE Marking validates that MedVision Dx Pro meets stringent EU safety, health, and environmental protection requirements for Class IIa medical devices. The platform integrates proprietary deep learning algorithms that analyze computed tomography (CT) and magnetic resonance imaging (MRI) scans in real-time, flagging abnormalities and providing quantitative measurements to radiologists and clinicians. According to recent industry analysis, the European healthcare AI market is projected to reach €143.02 billion by 2033, with 60% of European hospitals expected to deploy AI for diagnostics by 2030 . This regulatory milestone positions MedVision AI at the forefront of a rapidly expanding sector.
Clinical validation data from a multi-center study involving 2,400 patients across eight European hospitals demonstrated the platform’s efficacy. The software achieved 94.3% sensitivity and 91.7% specificity in detecting pulmonary nodules, hepatic lesions, and musculoskeletal abnormalities compared to standard radiologist interpretation alone. Notably, the technology reduced average diagnostic interpretation time by 39% while identifying 12% more incidental findings that required follow-up care. The study, conducted under the supervision of the European Society of Radiology, adhered to MDR requirements for clinical evidence and post-market surveillance.
“The CE Mark represents more than regulatory approval—it validates our commitment to developing AI that genuinely enhances clinical decision-making without replacing physician expertise,” said Dr. Elena Vasquez, CEO and co-founder of MedVision AI. “European radiologists face increasing imaging volumes and workforce shortages. Our platform acts as a second reader, allowing them to focus on complex cases while maintaining diagnostic accuracy and efficiency.”
The approval comes as European healthcare systems accelerate AI adoption to address mounting pressures. The EU Medical Device Regulation has certified fewer than 18,500 product agreements from over 28,500 applications submitted since 2021, highlighting the rigorous evaluation process that MedVision AI has successfully navigated. The company’s quality management system received MDR certification in Q3 2025, paving the way for this product-specific approval.
MedVision Dx Pro integrates seamlessly with existing picture archiving and communication systems (PACS) and hospital information systems through standard DICOM protocols. The platform processes imaging data on-premises, ensuring compliance with GDPR and European data sovereignty requirements. Unlike cloud-dependent solutions, this architecture addresses cybersecurity concerns while delivering sub-90-second analysis for standard chest CT studies.
Market analysts project that AI in medical imaging will maintain the largest market share within European healthcare AI applications through 2030, driven by demonstrated return on investment and regulatory clarity. MedVision AI plans immediate commercial launch in Germany, France, and the Netherlands, with phased rollout across Southern and Eastern Europe through established distributor partnerships with Siemens Healthineers and Philips Healthcare.
The company’s regulatory roadmap includes FDA 510(k) submission in Q1 2026 and expansion into cardiology and neuroimaging modules currently in clinical trials. Post-market clinical follow-up studies will track real-world performance across 5,000 patients annually as required by MDR Article 86.
About MedVision AI
MedVision AI is a privately held health technology company headquartered in Amsterdam, specializing in AI-powered diagnostic support software for medical imaging applications. Founded in 2021 by radiologists and machine learning researchers from University Medical Center Utrecht, the company develops on-premises AI solutions that assist physicians in detecting, characterizing, and monitoring diseases across radiology, cardiology, and oncology. MedVision AI has received grant funding from the European Innovation Council and participates in the EU-funded AI4Health imaging consortium.
Media Contact
Sarha Al-Mansoori
Director of Corporate Communications
G42
Email: media@g42.ai
Phone: +971 2555 0100
Website: www.g42.ai
