GE HealthCare achieves MRI portfolio milestone with FDA clearances for next-generation SIGNA MRI technology designed to enhance precision imaging and clinical efficiency
MWN-AI** Summary
GE HealthCare has recently achieved a significant milestone in its MRI portfolio with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for three next-generation MRI systems: SIGNA Sprint with Freelium, SIGNA Bolt, and the AI-driven SIGNA One ecosystem. These innovations are designed to enhance precision imaging and operational efficiency amid the growing demand for MRI procedures due to an aging population and increasing disease prevalence.
The SIGNA Sprint with Freelium is a groundbreaking 1.5T sealed magnet MRI system that boasts helium-free technology, allowing for sustainable operations without sacrificing image quality. It features an intuitive interface and operational autonomy, making advanced imaging accessible in both urban and remote settings. This technology offers impressive ride-through time, high signal-to-noise ratios, and exceptional clarity, all while reducing power consumption.
On the other hand, the SIGNA Bolt is an advanced 3T MRI scanner engineered for precision diagnostics and clinical workflow efficiency. With a powerful 80/200 gradient system, it reduces energy consumption by approximately 30% compared to prior systems, demonstrating sustainability without compromising performance. The SIGNA Bolt also introduces new AIR Coil technology, enhancing patient comfort and reducing rescans.
Both systems are supported by the SIGNA One ecosystem, which employs AI-driven solutions to streamline workflows and improve the overall MRI experience. By reducing inefficiencies in imaging operations, SIGNA One aims to enhance both patient and technologist experiences.
As GE HealthCare aims to redefine MRI capabilities, these FDA clearances represent a crucial step in modernizing healthcare imaging and expanding access to advanced technology. According to Kelly Londy, President and CEO of MR at GE HealthCare, this innovation is vital for raising the standard of care globally.
MWN-AI** Analysis
GE HealthCare's recent FDA clearances for its next-generation SIGNA MRI technologies—SIGNA Sprint with Freelium and SIGNA Bolt—mark a significant step in the company’s efforts to address growing demands for advanced imaging solutions. With an increasingly aging population and rising diagnostic needs, GE has strategically positioned itself to lead in an evolving market, showcasing both innovation and sustainability.
Investing in the SIGNA portfolio presents several opportunities for healthcare providers focused on enhancing clinical efficiency and patient care. The SIGNA Sprint, a 1.5T MRI system designed with a sealed magnet, positions itself as a sustainable alternative by operating with minimal helium. This focus not only supports helium independence but also maintains high image quality and operational autonomy, catering to facilities ranging from major hospitals to remote clinics.
On the premium tier, the 3T SIGNA Bolt exemplifies sophisticated performance through its advanced gradient system, leading to better diagnostics and faster processing times. Its lower energy consumption and sustainable practices align well with the growing trend in healthcare to adopt eco-friendly technologies, thus appealing to investment in green healthcare solutions.
The integration of SIGNA One, an AI-driven workflow solution, further enhances efficiency. By streamlining operations and providing essential automation, technology adoption becomes less burdensome for healthcare teams, addressing burnout—a prevalent issue in the sector.
As GE HealthCare continues to innovate and achieve regulatory milestones, the focus on their MRI products could result in notable market advantages, making it a compelling consideration for investors. Monitoring further developments in facility deployments and market responses will be essential for discerning long-term investment viability in GE HealthCare’s expanding portfolio. Overall, GE's commitment to merging technological advancement with sustainable practices signifies its potential for future growth in the healthcare imaging landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- SIGNA Sprint with Freelium, a new 1.5T sealed magnet MRI system, combines a sustainable design with uncompromised image quality, and operational autonomy to expand access to advanced MR, even in remote settings.
- SIGNA Bolt, a new 3T MRI scanner, is engineered to support precision diagnostics, clinical efficiency, and advanced research capability.
- Both new systems are powered by SIGNA One, an ecosystem of AI-driven workflow solutions designed to reduce inefficiencies and support MRI exams from plan to scan and beyond.
GE HealthCare (Nasdaq: GEHC) announced today 510(k) clearance of three new magnetic resonance (MR) innovations with the U.S. Food and Drug Administration (FDA): SIGNA™ Sprint with Freelium™ 1 , a 1.5T sealed magnet MRI system; SIGNA™ Bolt 2 , an advanced 3T MRI scanner; and SIGNA™ One 3 , an AI-driven ecosystem of workflow solutions designed to help reduce inefficiencies and support MRI exams from plan to scan and beyond.
The new MRI systems and technology combat some of the most complex challenges facing the radiology landscape from a rising demand in procedures caused by a growing aging population, increase in disease incidences, workforce burnout and sustainability expectations. These regulatory milestones signal a significant step forward in GE HealthCare’s multi-year strategy to deliver a new wave of innovation and further differentiate its MR portfolio.
“Achieving FDA clearance of our next-generation SIGNA MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” said Kelly Londy, President and CEO, MR at GE HealthCare. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision. With this new SIGNA generation, we’re redefining what’s possible – aiming to bring smarter, faster, more sustainable and more consistent imaging to more patients, across more settings, with confidence.”
Delivering benefits of helium-free technology: SIGNA Sprint with Freelium
GE HealthCare’s new sealed magnet 1.5T MRI system – SIGNA Sprint with Freelium – offers helium-free technology without compromising clinical or operational efficiency. With less than 1% helium usage 4 , SIGNA Sprint with Freelium provides helium independence without driving higher power consumption requirements or sacrificing image quality. The system supports 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 a wide coverage of anatomies and clinical application. The system provides consistent clarity and diagnostic confidence, and offers:
- >5-hour ride-through time, which enables the Freelium magnet to withstand short and prolonged power outages avoiding operational disruption
- Identical high homogeneity specification as conventional magnet technology, ensuring the same excellent image quality
- The same power infrastructure as current conventional magnet, providing helium independence without increasing power consumption
Designed for maximum siting flexibility, SIGNA Sprint with Freelium features a ventless magnet that enables installation virtually anywhere — from major hospitals to remote regions — expanding access to advanced MR capabilities. The system also introduces two levels of operational autonomy: Scanning Autonomy through the intuitive SIGNA One interface to simplify workflows across technologist experience levels, and autonomous magnet monitoring, protection and recovery with intelligent sensors that automate ramp-down and ramp-up processes without requiring a field engineer — supporting uptime and reducing service dependency.
Elevating the Premium Tier: SIGNA Bolt 3T
SIGNA Bolt is GE HealthCare’s next-gen 3T MRI scanner, engineered to deliver precision diagnostics through powerful performance and sustainable design. Built on a deep learning foundation, the system streamlines clinical workflows and supports end-to-end imaging pathways while maintaining low energy consumption and operational costs.
At its core is an advanced 80/200 gradient system that delivers research-level performance with approximately 30% lower power consumption compared to previous-generation systems, enabling gradient capability. SIGNA Bolt also introduces a new AIR™ Coil suite designed to enhance patient comfort and operational flexibility, including feet-first capabilities across exams to better support claustrophobic patients and help reduce costly rescans. SIGNA Bolt provides end-to-end advanced solutions supporting care pathways such as neurology and oncology.
The system’s sustainable infrastructure profile further differentiates its value proposition:
- Up to 65% reduction in peak power demand 5
- Up to 34% reduction in minimum equipment room space 5
Enhancing workflow with AI-driven solutions: SIGNA One
SIGNA Sprint with Freelium and SIGNA Bolt are powered by SIGNA One, a new AI-powered workflow ecosystem that offers solutions to improve the imaging experience and streamline MRI operations. By addressing inefficiencies across the MRI workflow, SIGNA One aims to help improve throughput, reduce variability and enhance the experience for both technologists and patients.
The SIGNA One platform integrates multiple core AI-enabled workflow solutions to enhance both the patient and user experience and elevate clinical confidence:
- An intuitive user experience that may help reduce training time with virtually zero learning curve, which boosts productivity for new and less experienced users
- The SIGNA One Table, designed to enhance patient comfort and simplify patient transport
- A fully automated SIGNA One Camera with In-Room Console live feed, AI-enabled anatomical 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
“As imaging volumes continue to climb, we’re under constant pressure to deliver answers faster without compromising diagnostic quality. What sets this new SIGNA MR platform apart is the focus on real-world clinical workflow. From the AI-driven automation to the dramatically streamlined setup and scanning process, we’re seeing meaningful reductions in exam time and far greater consistency across technologists. It’s a true leap forward in efficiency – one that will directly benefit both the patients we serve and our staff,” said Dr. Tiron C.M. Pechet, Assistant Medical Director and CMIO at Shields Health. “At Shields, advancing imaging technology is central to who we are — particularly innovations that elevate both the care experience and image quality — and we’re excited about the future impact technologies like this can have on the communities we serve.”
Advancing MR Leadership
Since its spinoff from GE in 2023, GE HealthCare has made significant investments to modernize and elevate its premium MR portfolio and strengthen its leadership position. The FDA clearances of SIGNA Sprint with Freelium, SIGNA Bolt and SIGNA One, with anticipated CE mark before the end of 2026, reflect the company’s strategic focus on innovation, sustainability and productivity and its ambition to shape the future of MR imaging.
Together, these advancements reinforce GE HealthCare’s commitment to partnering with healthcare providers to deliver precision care, improve operational performance and expand access to advanced imaging technologies.
For more information on next-gen SIGNA MR technology, visit gehealthcare.com/products/magnetic-resonance-imaging .
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2026 Fortune World’s Most Admired Companies™.
Follow us on LinkedIn , Facebook , Instagram , or visit our website for our latest news and perspectives .
1 SIGNA™ Sprint with Freelium™ is a sealed configuration of SIGNA™ Sprint Select. SIGNA Sprint Select is 510(k) cleared by the FDA. Not CE marked. Not available for sale in all regions.
2 SIGNA Bolt is 510(k) cleared by the U.S. FDA. Not CE marked. Not available for sale in all regions.
3 SIGNA One represents features and content that are 510(k) cleared with SIGNA Bolt and SIGNA Sprint with Freelium by the U.S. FDA. Not CE marked. Not available for sale in all regions.
4 Compared to conventional magnets.
5 Compared to previous generation systems.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260218071310/en/
GE HealthCare Media Contact:
Katie Scrivano
M +1 262-215-5281
Katherine.Scrivano@gehealthcare.com
FAQ**
How does GE HealthCare Technologies Inc. GEHC plan to leverage the FDA clearance of SIGNA Sprint with Freelium and SIGNA Bolt to expand its market share in the MRI industry, particularly in remote regions where access to MRI technology is limited?
Given the increasing demand for MRI procedures, how is GE HealthCare Technologies Inc. GEHC ensuring that the SIGNA One AI-driven ecosystem effectively addresses inefficiencies in clinical workflows while maintaining high diagnostic precision?
What strategies is GE HealthCare Technologies Inc. GEHC implementing to market the sustainability benefits of its helium-free SIGNA Sprint with Freelium system compared to traditional MRI systems that rely on helium?
As competition in the imaging technology market intensifies, how does GE HealthCare Technologies Inc. GEHC differentiate the new SIGNA MRI systems in terms of cost-effectiveness and operational efficiency for healthcare providers?
**MWN-AI FAQ is based on asking OpenAI questions about GE HealthCare Technologies Inc. (NASDAQ: GEHC).
NASDAQ: GEHC
GEHC Trading
-1.68% G/L:
$75.16 Last:
835,436 Volume:
$75.72 Open:
