Barcelona, Spain (June 19, 2025) – ABCDx, S.L. a pioneering biotech company transforming stroke diagnostics, proudly announces a strategic partnership with Minosia, a leader in digital and AI-supported regulatory affairs. This collaboration represents a key milestone in ABCDx, S.L. mission to bring its Large Vessel Occlusion (LVO) stroke diagnostic solution to market with state-of-the-art regulatory compliance and operational efficiency.
Leveraging Minosia’s AI-powered regulatory intelligence platform, ABCDx, S.L. will streamline its compliance roadmap with critical standards including the In Vitro Diagnostic Regulation (IVDR), ISO13485, and ISO 14971. This partnership ensures that ABCDx, S.L.’s innovative solutions not only meet but anticipate evolving global regulatory demands.
“We are very excited to partner with Minosia, whose innovative integration of artificial intelligence into regulatory workflows offers us both strategic clarity and operational speed. Minosia’s platform streamlines regulatory work by identifying nonconformities, suggesting corrective actions, and supporting the ABCDx, S.L. team in applying standards more effectively, combining smart automation with essential human validation,” said Yolanda Fernandez, Quality Assurance & Regulatory Affairs Compliance Lead at ABCDx,S.L. “This collaboration is a significant step forward and reinforces our commitment to building a robust, forward-looking compliance framework for our LVO stroke solution”.
“ABCDx,S.L. is committed to clinical excellence and patient safety, and Minosia’s AI-enhanced tools are helping us raise the bar,” added Jean-Charles Sanchez, CEO of ABCDx, S.L. “This partnership empowers our team to focus on delivering life-saving diagnostic innovation while maintaining full regulatory alignment across jurisdictions.”
About ABCDx
ABCDx is a clinical-stage biotech company based in Switzerland and Spain, specializing in breakthrough diagnostic solutions for brain injury, including stroke and traumatic brain injury. With a foundation in translational research and a vision to improve emergency care outcomes, ABCDx is developing next-generation tools that combine biomarkers and digital technology for real-time, point-of-care decision support.
About Minosia
Minosia is a next-generation AI platform for regulatory affairs that combines deep sector expertise with cutting-edge tools to accelerate and de-risk compliance processes for medtech and biotech companies. Based in Europe, Minosia supports clients worldwide across the entire product lifecycle.
Contact
ABCDx
Tamara Sefcovicova
PR, Marketing and Office Operations Specialist
tamara.sefcovicova@abcdx.ch
Minosia
Eskil Sköldkvist
Co-founder & CEO
eskil@minosia.com
www.minosia.com
