GE HealthCare has obtained US Food and Drug Administration (FDA) clearance for a trio of new products within its Signa MRI portfolio, as the company looks to consolidate its dominant market position with more power-efficient machinery.
The first of these clearances went to Signa Sprint with Freelium, a new sealed magnet 1.5T MRI system integrated with GE HealthCare’s AIR Recon deep learning (DL) and Sonic DL tools. Sprint is reliant on less than 1% helium usage as compared with conventional magnets. According to GE HealthCare, the system’s helium-free technology cuts down on power consumption requirements without sacrificing image quality. Also featuring a ventless magnet and a five-hour ride time in the event of power outages, GE HealthCare highlighted that the system is equally suitable for installation in major hospitals and remote care settings.
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The FDA also cleared Signa Bolt, GE HealthCare’s next-generation 3T MRI scanner. Suitable for care pathways including neurology and oncology, Bolt is touted as having a 30% lower power consumption than previous Signa systems. According to GE HealthCare, with the system’s infrastructure designed with sustainability in mind, it achieves a 65% reduction in peak power demand versus previous systems in this range.
Bolt also introduces a first in the Signa range with the AIR Coil suite. With feet-first capabilities across exam types, the new suite is intended to better support claustrophobic patients and reduce the need for rescans.
Sprint and Bolt are each powered by Signa One, a new artificial intelligence (AI)-based workflow platform. The software includes features to help improve workflow efficiencies and patient setup. With FDA clearance in hand, GE HealthCare said the new Signa products are also expected to gain European CE marks by the end of 2026.
Kelly Londy, president and CEO of magnetic resonance at GE HealthCare, said: “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.
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By GlobalData“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.”
According to analysis by GlobalData, GE HealthCare owns a market-leading share in the North American MRI market.
GE HealthCare recently reported revenue of $20.6bn in 2025. The company’s imaging portfolio was the most significant revenue driver, accounting for $9.25bn of the year’s total revenue, reflecting a 4.4% uptick on $8.86bn in FY24.
