Subtle Medical’s SubtleHD™(MR) Wins 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 14, 2025  – 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, reducing variability and improving consistency across longitudinal studies. Currently supports 3D brain sequences. (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, Ph.D., 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

SOURCE: Subtle Medical, Inc.