SubtleHD™ Receives Health Canada Approval to Improve MRI Access and Efficiency
Subtle Medical has announced that its AI-powered MRI enhancement software, SubtleHD™, has received Health Canada approval, allowing healthcare providers across Canada to adopt the technology. Designed to significantly improve both the speed and quality of MRI imaging, SubtleHD™ offers a vendor-neutral, software-only solution that integrates into existing systems—delivering results without requiring new scanners or costly hardware upgrades.
The approval comes at a pivotal moment for Canada’s healthcare system, which continues to grapple with some of the longest medical imaging wait times in the developed world. According to the Canadian Association of Radiologists, MRI wait times in certain provinces can extend beyond three to six months, delaying diagnosis and treatment for conditions like cancer, neurological disorders, and musculoskeletal injuries. In Ontario, for example, over 80% of patients wait longer than the recommended 28-day timeframe for an MRI scan, underscoring the urgent need for more efficient imaging solutions.
SubtleHD™ addresses this need with several core capabilities. First, it enhances image quality through advanced denoising and sharpening, enabling higher diagnostic confidence even when used on older MRI equipment. The software also allows for up to 80% faster imaging sequences, which in turn boosts scan throughput, enables more patient appointments per day, and helps alleviate appointment backlogs. This efficiency gain directly contributes to improved patient care by reducing scan-related discomfort, minimizing motion artifacts, and accelerating access to timely diagnoses.
The software is part of Subtle-ELITE™, Subtle Medical’s flagship suite of MRI enhancement tools. While SubtleSYNTH™ and SubtleALIGN™ are still awaiting regulatory approval, SubtleHD™ is now commercially available in Canada as a standalone product. Once approved, all three modules will form a comprehensive AI enhancement platform designed to optimize image quality, increase speed, and automate workflows across MRI services.
In discussing the significance of this regulatory milestone, Josh Gurewitz, Chief Commercial Officer at Subtle Medical, emphasized that Health Canada's clearance opens the door for immediate adoption by Canadian imaging facilities. He noted that SubtleHD™ allows providers to scale imaging operations without needing to invest in new infrastructure, thus reducing staff burnout and helping deliver faster, more accurate diagnoses to patients.
Canadian radiology leaders have consistently called for innovative, scalable solutions to meet growing imaging demands. SubtleHD™ rises to that challenge by enabling radiology departments to do more with existing resources—offering better performance and patient throughput without increasing operational complexity. Its vendor-agnostic design means that the software can be easily integrated into various imaging environments, regardless of existing hardware vendors.
With SubtleHD™ now approved for use in Canada, healthcare providers have a new tool to combat long wait times and resource constraints, while advancing the overall quality and accessibility of MRI diagnostics. The rollout is expected to contribute significantly to streamlining radiology services nationwide and ultimately enhancing patient outcomes across diverse medical settings.