PALO ALTO – April 17, 2025 – LVIS Corporation, a trailblazer in AI-driven neurological diagnostics, proudly announced today that its NeuroMatch product suite has earned ISO 13485 certification. This globally recognized standard for quality management systems in medical devices validates LVIS’s unwavering commitment to delivering safe, reliable, and high-performing solutions that empower clinicians and improve patient outcomes.
The ISO 13485 certification encompasses the entire NeuroMatch portfolio—NeuroMatch Access, NeuroMatch Pro, and NeuroMatch Elite—affirming that LVIS has implemented a robust quality management system across the design, development, and manufacturing processes. At the heart of NeuroMatch lies its groundbreaking ability to generate a digital twin of brain function using advanced EEG interpretation. This technology provides clinicians with precise, actionable insights into neurological activity, revolutionizing the diagnosis and management of brain-related conditions. By achieving this certification, LVIS reinforces its dedication to upholding the highest standards of safety and effectiveness, ensuring that NeuroMatch meets the stringent demands of healthcare professionals worldwide.
The certification positions LVIS as a trusted leader in the global medical device landscape, facilitating upcoming international regulatory registrations, including compliance with the European Union Medical Device Regulation (EU MDR). This step accelerates the company’s efforts to bring NeuroMatch’s innovative diagnostics to healthcare systems worldwide, addressing critical needs in neurological assessment and treatment. With its AI-powered platform, LVIS is poised to enhance clinical workflows, improve diagnostic accuracy, and ultimately broaden access to advanced brain care for patients across diverse regions.
David Cash, CEO of LVIS Corporation, issued the following statement:
“This milestone marks a pivotal moment for LVIS. Earning ISO 13485 certification reflects our rigorous focus on quality and patient safety while paving the way for expanded regulatory approvals in key markets like Europe, Middle East, and Southeast Asia.”
For more information about LVIS Corporation and the NeuroMatch product suite, visit www.lvis.com.
About LVIS Corporation
LVIS Corporation, headquartered in Palo Alto, California, is an innovator in AI-driven neurotechnology, dedicated to transforming neurological diagnostics and patient care. Through its NeuroMatch platform, LVIS provides advanced EEG interpretation and brain function modeling, enhancing diagnostic accuracy and clinical workflows. Committed to expanding global access to neurological care, LVIS continues to lead in medical technology innovation and regulatory excellence.