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.

Compared with other image enhancement solutions, Subtle-ELITE™ drives greater value to radiologists and imaging institutions by combining three new tools into one package that optimizes the MRI workflow like never before.

The Subtle-ELITE™ package includes:

1. SubtleHD™ – Uses advanced denoising and sharpening, producing ultra-clear images that often exceed standard-of-care quality. It also enables significantly faster scan protocols – some up to 80% – and is applicable to all body regions. (FDA-Cleared)
2. SubtleSYNTH™ – Leverages deep learning to generate MR imaging contrasts from existing sequences, achieving 100% acceleration and producing STIR images in 0 minutes. Currently available for spine STIR with expansion to additional body regions underway. (FDA-Cleared)
3. SubtleALIGN™ – Automatically aligns brain MR to ideal anatomical position with 97%+ accuracy, reducing variability and improving consistency across longitudinal studies. Currently supports 3D brain sequences with the option to generate orthogonal reformats. (FDA-Cleared)

Subtle Medical was the first to market with third-party AI-powered image enhancement software solutions with the release of SubtleMR™ and SubtlePET™, which are deployed in over 16 countries worldwide. SubtleHD™ builds on this foundation, taking advantage of convolutional neural networks to deliver sharper and clearer images while achieving even greater time savings compared to SubtleMR™. Book a demo

Redefining MRI Performance Across All Scanners:

• Faster, More Efficient Imaging – Reduces scan times while maintaining or exceeding image quality standards.
• Higher Patient Throughput & Operational ROI – Allows imaging centers to add additional slot times to serve more patients without additional equipment investments.
• Superior Patient Experience – Enables hospitals and imaging institutions to increase patient comfort by reducing time spent in the scanner.
• Vendor-Neutral Compatibility – Works with all MRI scanners, regardless of manufacturer or model.
• Extended Scanner Lifespan – Virtually upgrades existing MRI scanners, delaying costly capital expenditures.

“The FDA clearance of Subtle-HD™ marks a significant milestone in AI-driven radiology, giving hospitals and imaging centers a powerful solution to increase efficiency, improve image quality, and optimize workflows—all without additional hardware costs,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. “By combining SubtleHD, SubtleSYNTH, and SubtleALIGN into a single, comprehensive package, Subtle-ELITE™ is setting a new benchmark for the future of MRI.”

Attend the Aunt Minnie webinar on Subtle-ELITE taking place on March 19, 2025, at 10am PT / 1pm ET.  Register to Save Your Seat

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions designed to enhance the efficiency, quality, and accessibility of medical imaging. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to advancing healthcare through AI-driven innovation. Its solutions are deployed worldwide, helping imaging centers and hospitals optimize workflows, improve scanner sustainability, and improve patient care. For more information, visit subtlemedical.com or contact sales@subtlemedical.com.

Media Contact:
Anna Menyhart-Borroni
Head of Global Marketing
anna@subtlemedical.com

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SOURCE Subtle Medical, Inc.