SubtleHD™ Gains Health Canada Approval to Support MRI Efficiency Improvements

SubtleHD delivers breakthrough efficiency and image quality to address Canada's urgent need for faster MRI access.

MENLO PARK, Calif., May 14, 2025 /PRNewswire/ -- Subtle Medical, a global leader in AI-powered medical imaging enhancement, today announced that SubtleHD™ has received Health Canada approval, officially expanding access to its cutting-edge MRI image enhancement software to healthcare providers across Canada. SubtleHD is designed to dramatically reduce MRI scan times, with some sequences up to 80% faster, improve image quality, and enhance radiology workflows—all without the need for new hardware.

This clearance comes at a critical time for Canada's healthcare system. Wait times for medical imaging in the country are among the longest in the developed world. According to the Canadian Association of Radiologists, MRI wait times can stretch beyond 3 to 6 months in some provinces【¹】. In Ontario alone, more than 80% of patients wait longer than the recommended 28 days for an MRI scan【²】, often delaying diagnosis and treatment for serious conditions, including cancer, neurological disease, and musculoskeletal injuries.

SubtleHD™ will provide Canadian hospitals and imaging centers with:

• Superior Image Quality – Enhances diagnostic confidence even on older MRI machines, with advanced denoising and sharpening across all body parts, sequences, and contrasts.
• Dramatically Faster Scans – Enables up to 80% shorter sequences, helping facilities increase daily scan volume, add additional slot times, and reduce backlogs.
• Vendor-Neutral Integration – Seamlessly integrates into existing MRI infrastructure without requiring scanner replacements or upgrades.
• Improved Patient Care – Shorter scans reduce patient discomfort, lower the need for rescans due to motion artifacts, and help accelerate access to diagnosis.

SubtleHD™ is part of Subtle-ELITE™, an industry-first MRI enhancement package that also includes SubtleSYNTH™ and SubtleALIGN™—all designed to dramatically improve image quality, speed, and workflow automation. While SubtleSYNTH and SubtleALIGN are currently pending, SubtleHD™ is now commercially available in Canada as a standalone solution. Once approved, all three products will be offered together as a powerful, integrated AI package for MRI providers.

"Health Canada's clearance of SubtleHD™ is a vital milestone for improving the accessibility and quality of MRI across the country," said Josh Gurewitz, Chief Commercial Officer at Subtle Medical. "With this approval, healthcare providers in Canada can immediately begin using our AI to expand imaging capacity, reduce burnout, and deliver faster diagnoses for patients—without needing to buy a new scanner."

Canadian imaging leaders have repeatedly emphasized the need for innovative solutions that can scale quickly. SubtleHD™ answers that call by empowering radiology departments to do more with less: more patients, better image quality, and greater efficiency from the same resources.

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. 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 driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical's solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care. Learn more and request a demo at www.subtlemedical.com.

Media Contact:
Anna Menyhart-Borroni
Head of Global Marketing
[email protected]

Sources for reference:

Canadian Association of Radiologists, 2024 Wait Time Report
Ontario Health Quality Report, "Measuring Wait Times for Diagnostic Imaging" 2023

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SOURCE Subtle Medical, Inc.