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GE HealthCare’s SIGNA MAGNUS MRI scanner gains FDA clearance
GE HealthCare has announced the Food and Drug Administration (FDA) 510(k) clearance for its SIGNA MAGNUS magnetic resonance imaging (MRI) scanner. The 3.0T high-performance, head-only scanner is ...
pharmaphorum2y
FDA okays ProstatID software for detecting prostate cancer in MRI
Magnetic resonance imaging (MRI) technology specialist Bot Image has won FDA approval for its artificial intelligence-powered software ProstatID, used for the detection and diagnosis of prostate ...
Morningstar1mon
Subtle Medical's SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed
Feb. 13, 2025 /PRNewswire/ -- Subtle Medical, the global leader in AI-powered medical imaging enhancement, announced today the FDA clearance for Subtle-HD™, the industry's most advanced MRI ...
Medscape9d
MRI Screening after Silicone Implant Breast Surgery: Patient Survey of Adherence to FDA Recommendations.
BACKGROUND: The FDA recommends women with silicone breast implants undergo MRI surveillance to detect asymptomatic rupture. Screening is costly and often not covered by insurance. We assessed ...