Subtle Medical Achieves FDA Clearance for SubtleSYNTH™ Software

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Key Highlights

  • Subtle Medical announces FDA clearance for SubtleSYNTH™, an AI-based solution.
  • SubtleSYNTH™ generates synthetic STIR images from T1 and T2 weighted contrasts.
  • Validated for spine use through a demographically diverse study published in AJNR.
  • NIH SBIR grant of $2.3 million awarded for further expansion in brain and MSK imaging.
  • Enhances operational efficiency and reduces acquisition time to zero for MRI sequences.

Source: PR Newswire

Notable Quotes

  • “SubtleSYNTH represents a significant advancement by reducing acquisition time for a common MRI sequence to zero, enhancing operational efficiency.” — Ajit Shankaranarayanan, Chief Product Officer at Subtle Medical
  • “These innovations are poised to not only redefine the landscape of diagnostic imaging, but also simplify the ever increasing complexity of workflows faced by technologists and radiologists alike.”  Josh Gurewitz, Chief Commercial Officer at Subtle Medical

SoHC's Take

The FDA clearance of Subtle Medical’s SubtleSYNTH™ marks a pivotal development in the medical imaging field. By leveraging deep learning to produce synthetic STIR images with zero acquisition time, SubtleSYNTH™ not only enhances operational efficiency but also addresses critical challenges such as reducing motion artifacts and easing the workload on radiologists and technologists. The substantial NIH SBIR grant underscores the technology’s potential and the confidence in its future expansions into brain and MSK imaging. This breakthrough signifies a major leap forward in the quest for faster, higher-quality MRI imaging and promises significant improvements in patient care and diagnostic accuracy.

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