GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics
Shots:
- The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations
- SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation in diverse settings
- Both systems are powered by SIGNA One, an AI-driven MRI workflow platform & NVIDIA-accelerated deep learning to improve efficiency, consistency, & throughput
Ref: GE HealthCare | Image: GE HealthCare | Press Release
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