Subtle Medical’s SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed
With FDA clearance of SubtleHD™, Subtle Medical launches Subtle-ELITE™, an industry-first AI package designed to achieve superior image quality, unprecedented speed, and workflow automation
MENLO PARK, Calif., 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 acceleration and enhancement software to date. This approval marks the official launch of Subtle-ELITE™, a first-to-market AI-powered suite that includes three software tools: SubtleHD™, SubtleSYNTH™, and SubtleALIGN™, all collectively designed to dramatically improve image quality and reduce MRI scan times with an 80% scan time reduction in certain sequences.
