GE HealthCare announced U.S. Food and Drug Administration (FDA) 510(k) clearance of three new magnetic resonance (MR) technologies:

• SIGNA Sprint with Freelium, a 1.5T sealed magnet MRI system
• SIGNA Bolt, an advanced 3T MRI scanner
• SIGNA One, an artificial intelligence (AI)-driven ecosystem of workflow solutions

The company said the new MRI systems and tech address complex radiology challenges including rising procedural demand from a growing aging population, increase in disease incidences, workforce burnout, and sustainability expectations.

“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.”

SIGNA Sprint with Freelium

The sealed magnet 1.5 T MRI system uses less than 1% helium, offering helium independence without driving higher power consumption requirements or sacrificing image quality. It supports image quality through homogeneity, high signal-to-noise ratio (SNR), and image clarity, integrated with deep learning solutions AIR Recon DL and Sonic DL.

It has an under five-hour ride-through time so the Freelium magnet can withstand short and prolonged power outages. It features identical high homogeneity specification as conventional magnet technology, as well as the same power infrastructure as current conventional magnets.

SIGNA Bolt 3T MRI

Built on a deep learning foundation, this MRI has an 80/200 gradient system that provides research-level performance with about 30% lower power consumption compared to previous-generation systems. It introduces a new AIR Coil suite, which allows feet-first capabilities in exams to better support claustrophobic patients.

The system supports neurology and oncology. Its sustainable profile offers up to 65% reduction in peak power demand, and up to 34% reduction in minimum equipment room space.

SIGNA One

Both SIGNA Sprint with Freelium and SIGNA Bolt are powered by this AI workflow ecosystem that provides solutions to improve the imaging experience and streamline MRI operations. An intuitive user experience can help reduce training time with virtually zero learning curve, and its table is designed to boost patient comfort and simplify transport.

A fully automated camera with in-room console live feed, AI-enabled anatomical landmark location and patient positioning verification with real-time visual guidance on a touchscreen display aim to improve speed and accuracy of patient setup. Contactless respiratory and peripheral gating is designed to capture physiological data regardless of patient orientation and without external devices.

Earlier this week, GE HealthCare revealed a new $35 million deal with BARDA to advance artificial intelligence-powered ultrasound for trauma care and emergency preparedness.