Nov. 30, 2025 — GE HealthCare has announced the 510(k) submissions to the U.S. Food and Drug Administration (FDA) seeking clearance for next-generation SIGNA MRI technology. Unveiled at RSNA 2025, these differentiated solutions are part of a wave of new GE HealthCare innovations aimed at tackling complex healthcare challenges. 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.
With imaging needs outpacing the radiologist workforce5, leading to longer wait times, burnout and delays in diagnosis, many departments are struggling to keep pace. At the same time, aging equipment and flat reimbursement rates are pushing providers to seek smarter, more sustainable solutions.
“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.”
SIGNA Bolt
SIGNA Bolt6 is the company's most advanced high-field, clinical wide bore 3.0T MRI system and combines ultra-high gradient performance, intelligent digital radio frequency (RF) architecture and sustainable design to deliver precision imaging, fast workflows and seamless clinical-to-research flexibility, all with exceptionally low energy consumption and operational costs.
SIGNA Bolt includes:
- The power to deliver diagnostic quality in everyday scans with outstanding gradient and RF performance for research and clinical applications
- Next-gen AI-enabled workflow of SIGNA One in combination with deep learning applications designed to enable accelerated exam times
- Deep-learning based advanced applications that aim to enhance diagnostic capabilities
- End-to-end clinical pathway solutions from planning to reporting for neurology and oncology
- Advanced developer toolkits to simplify research
SIGNA Sprint with Freelium
SIGNA Sprint with Freelium7 aims to broaden access to sustainable and equitable MRI technology. With less than 1% helium usage8, Freelium is designed to provide effortless sustainability without compromising clinical and operational efficiency.
The SIGNA Sprint with Freelium 1.5T system is designed to support remarkable image quality through exceptional homogeneity, high signal-to-noise ratio (SNR) and image clarity. Integrated with deep learning solutions, including AIR Recon DL and Sonic DL with wide coverage of anatomies and clinical applications, the system aims to provide consistent clarity and diagnostic confidence.
The Freelium ventless magnet is designed to allow installation virtually anywhere – from hospitals to remote regions, expanding access to advanced MR capabilities for more patients. SIGNA Sprint with Freelium has two levels of operational autonomy to empower radiology departments: Scanning Autonomy with SIGNA One Interface, an intuitive user interface aiming to simplify scanning, and Autoramp with intelligent sensors designed to support automated magnet recovery and supporting system uptime without the need for a field engineer.
SIGNA Sprint with Freelium includes:
- A design that uses less than 1% helium versus conventional designs9 with no additional power or cooling required
- MR magnet installation virtually anywhere
- Exceptional homogeneity10 designed for impressive image quality and diagnostic capability
SIGNA One11
A next-gen, AI-powered workflow platform that is designed to improve the imaging experience by combining precision with simplicity, SIGNA One offers five innovations at its core designed to streamline operations and elevate clinical confidence.
“We’re dedicated to making every interaction smooth, fast and patient centric by using predictive technology that boosts efficiency,” said Bryan Mock, PhD, General Manager, Global Product Segment, Premium MR, GE HealthCare. “SIGNA One technology is designed to simplify and improve the efficiency of experienced users, while aiming to shorten the learning curve for new users. Regardless of a users’ experience level, SIGNA One aims to liberate users from inefficiencies at every stage of the MR imaging process.”
SIGNA includes12:
- An intuitive user experience that may help reduce training time and aims to boost productivity while aiming to shorten the learning curve for new and less experienced users
- The SIGNA One Table, designed to enhance patient comfort and simplify patient transport
- Fully automated SIGNA One Camera with In-Room Console live feed, AI-enabled landmark localization and patient positioning verification, with real-time visual guidance on a touchscreen display — aiming to improve speed and accuracy of patient setup
- Contactless respiratory and peripheral gating designed to capture physiological data effortlessly, regardless of patient orientation and without the need for external devices
- High-resolution, In-Room Consoles empowering technologists with simple patient setup control, aiming to minimize interruptions and maximizing throughput
GE HealthCare is integrating with NVIDIA technology to enhance the performance and intelligence of its MR products by utilizing NVIDIA GPUs to accelerate the development of deep learning reconstruction models. Accelerated by NVIDIA’s RTX product line and programmed with the new SIGNA One MRI Workflow solutions and advanced deep learning tools that are designed to elevate the user and patient experience, SIGNA Bolt and SIGNA Sprint with Freelium are designed to provide powerful imaging techniques for tailored patient care.
Learn more about these and other GE HealthCare MRI technologies at GE HealthCare’s booth #7334 at RSNA 2025.
- SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.
- SIGNA Sprint with Freelium is a configuration of SIGNA Sprint Select. SIGNA Sprint Select is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.
- SIGNA One is 510(k) pending with the U.S. FDA. Not CE marked. Not available for sale.
- Helium-free: Helium is permanently enclosed in the magnet.
- Harvey L. Neiman Health Policy Institute, 2025.
- SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked, not available for sale.
- SIGNA Sprint with Freelium is a sealed configuration of SIGNA Sprint Select, 510(k) pending at the U.S. FDA. Not CE marked, not available for sale.
- Compared to conventional magnets.
- Helium-free: Helium is permanently enclosed in the magnet
- as conventional IPM magnet.
- SIGNA One represents features of SIGNA Bolt and SIGNA Sprint Select which are 510(k) pending at U.S. FDA. Not yet CE marked. Not available for sale.
- All features may not be included in all system configurations.
December 10, 2025 