GE HealthCare announces 510k submissions to FDA for SIGNA MRI technology

GE HealthCare (GEHC) announced the 510(k) submissions to the U.S. Food and Drug Administration, FDA, seeking clearance for next-generation SIGNA MRI technology. Unveiled at the Radiological Society of North America’s 2025 Annual Meeting, these differentiated solutions are part of a wave of new GE HealthCare innovations aimed at tackling some of the most complex challenges in healthcare. Designed to enhance precision diagnosis for clinicians and help clinicians improve patient outcomes, the new technologies include GE HealthCare’s4 1.5T MRI system, both equipped with an AI-powered workflow platform designed for end-to-end exam efficiency. “The urgency for greater access, efficiency and precision in MRI has never been greater. We’ve listened to clinicians who are seeking smarter, more sustainable technologies to meet today’s challenges and tomorrow’s needs,” said Kelly Londy, President & CEO, MR, GE HealthCare. “With the introduction of our advanced SIGNA lineup, we’re delivering on a bold vision for MRI – one that intentionally puts smarter technology to work for clinicians and patients alike to make MRI more intuitive, more efficient, and more impactful in everyday care.”