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GE HealthCare achieves MRI portfolio milestone with FDA clearances for next-generation SIGNA MRI technology designed to enhance precision imaging and clinical efficiency
SIGNA Sprint with Freelium, a new 1.5T sealed magnet MRI system, combines a sustainable design with uncompromised image quality, and operational autonomy to
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nSIGNA 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.\n\n\n\nSIGNA Bolt, a new 3T MRI scanner, is engineered to support precision diagnostics, clinical efficiency, and advanced research capability.\n\n\n\nBoth 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.\n\n\n\n CHICAGO--(BUSINESS WIRE)--\nGE 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™ Bolt2, an advanced 3T MRI scanner; and SIGNA™ One3, an AI-driven ecosystem of workflow solutions designed to help reduce inefficiencies and support MRI exams from plan to scan and beyond.\n\n\nThe 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.\n\n\n“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.”\n\n\nDelivering benefits of helium-free technology: SIGNA Sprint with Freelium\n\n\nGE 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 usage4, SIGNA Sprint w...