par
Gus Iversen, Editor in Chief | February 25, 2026
GE HealthCare has received 510(k) clearance from the FDA for three MR imaging systems: the SIGNA Sprint with Freelium 1.5T system, the SIGNA Bolt 3T scanner and SIGNA One, an AI-enabled workflow platform.
The Chicago-based company said the clearances mark an update to its MR portfolio as imaging volumes rise and providers face staffing and infrastructure constraints.
SIGNA Sprint with Freelium is a sealed magnet 1.5T system designed to operate with less than 1% helium. GE HealthCare said the system maintains image quality and power requirements comparable to conventional magnets while offering a ventless design that may simplify siting. The scanner includes a claimed ride-through time of more than five hours during power interruptions, and incorporates deep learning reconstruction tools, including AIR Recon DL and Sonic DL. The system also supports automated magnet monitoring and recovery functions.
Ad Statistics
Times Displayed: 353261
Times Visited: 21073 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
SIGNA Bolt is a new 3T scanner built on an 80/200 gradient system. According to the company, it delivers research-level gradient performance with about 30% lower power consumption than prior-generation systems. GE HealthCare also cites reductions of up to 65% in peak power demand and up to 34% in minimum equipment room space. The system introduces a redesigned AIR coil suite and feet-first exam capabilities intended to address patient comfort and reduce repeat scans.
Both scanners are integrated with SIGNA One, a workflow platform that uses AI to automate elements of exam setup, patient positioning and image acquisition. Features include an in-room console, camera-based positioning assistance, and contactless respiratory and peripheral gating.
“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, CEO, MR at GE HealthCare.
Dr. Tiron C.M. Pechet, assistant medical director and CMIO at Shields Health, said the platform has led to “meaningful reductions in exam time and far greater consistency across technologists.”
GE HealthCare said it anticipates CE mark for the systems before the end of 2026.
