The FDA clearance paves the way for the official launch of an AI-powered MRI enhancement suite designed to improve imaging efficiency and quality.

Summary

Subtle Medical has received FDA clearance for SubtleHD, its AI-powered MRI acceleration and enhancement software. This approval marks the official launch of Subtle-ELITE, a suite that includes SubtleHD, SubtleSYNTH, and SubtleALIGN, all designed to improve MRI image quality and reduce scan times. The software enables up to an 80% reduction in scan times for certain sequences while enhancing image clarity and workflow efficiency, according to the company. Subtle-ELITE is vendor-neutral, compatible with all MRI scanners, and aims to improve patient throughput, reduce costs, and extend the lifespan of existing MRI systems.

Key Takeaways

  1. FDA Clears Subtle-HD, Enabling Subtle-ELITE Launch – The approval of SubtleHD allows Subtle Medical to officially launch Subtle-ELITE, a suite of AI-powered MRI tools designed to enhance imaging.
  2. Software Aims to Reduce MRI Scan Times – Subtle-ELITE’s AI-driven tools are designed to accelerate MRI scans while maintaining image quality, with certain sequences showing up to an 80% reduction in scan time.
  3. Compatible with Existing MRI Systems – The software is designed to integrate with MRI scanners from various manufacturers, allowing imaging centers to use the technology without additional hardware.

Subtle Medical, a provider of artificial intelligence (AI)-powered medical imaging enhancement, announced today the US Food and Drug Administration clearance for its SubtleHD MRI acceleration and enhancement software. 

This approval marks the official launch of Subtle-ELITE, an AI-powered suite that includes three software tools: SubtleHD, SubtleSYNTH, and SubtleALIGN, all collectively designed to improve image quality and reduce MRI scan times with an 80% scan time reduction in certain sequences.

Subtle-ELITE introduces a new approach to MRI image enhancement by combining three tools into a single package designed to optimize workflow efficiency and image quality. The Subtle-ELITE package includes:

  1. SubtleHD – Uses advanced denoising and sharpening, producing ultra-clear images. 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 magnetic resonance imaging contrasts from existing sequences, achieving 100% acceleration and producing short tau inversion recovery images in zero minutes. Currently available for spine short tau inversion recovery with expansion to additional body regions underway. (FDA-cleared)
  3. SubtleALIGN – Automatically aligns brain magnetic resonance to ideal anatomical position with over 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. 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, according to a release from the company. 

“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,” says Ajit Shankaranarayanan, PhD, chief product officer at Subtle Medical, in a release. “By combining SubtleHD, SubtleSYNTH, and SubtleALIGN into a single, comprehensive package, Subtle-ELITE is setting a new benchmark for the future of MRI.”

Photo caption: FDA clears SubtleHD

Photo credit: Subtle Medical