GE HealthCare (GEHC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for three MRI technologies: Signa Sprint with Freelium, a 1.5-tesla sealed magnet system; Signa Bolt, an advanced 3-tesla scanner; and Signa One, an AI-driven ecosystem of workflow solutions.
Signa BoltGE Healthcare
Signa Sprint with Freelium uses less than 1% helium and features a ventless magnet that enables installation in a range of settings, including remote regions, according to the company. The system integrates with GEHC's deep-learning reconstruction tools, AIR Recon DL and Sonic DL, and offers more than five hours of ride-through time during power outages, GEHC said.
Signa Bolt is built around an 80/200 gradient system and features a new AIR Coil suite that includes feet-first exam capabilities to support claustrophobic patients. The system offers up to 65% reduction in peak power demand and up to 34% reduction in minimum equipment room space compared with previous-generation systems, according to the firm.
Both systems are powered by Signa One, which features AI-enabled anatomical landmark localization, automated patient positioning, and contactless respiratory and peripheral gating. GE HealthCare said it anticipates receiving the CE Mark for all three technologies before the end of 2026.
