FDA Approves Revolutionary AI Software SubtleSYNTH™ for Faster MRI Scans

FDA Clears New AI-Powered MRI Software

The U.S. Food and Drug Administration (FDA) has granted clearance to Subtle Medical's latest innovation, SubtleSYNTH™, a software that leverages artificial intelligence to generate synthetic MRI images. This approval marks a significant milestone in improving the efficiency and quality of MRI scans.

SubtleSYNTH™, using deep learning algorithms, can produce synthetic STIR images from pre-existing T1 and T2 weighted contrasts without any additional scanning time. This advancement has been confirmed to be effective in spinal imaging through a study published in the American Journal of Neuroradiology (AJNR).

Enhancing MRI Speed and Quality

Subtle Medical has been a pioneer in the field of AI-driven medical imaging, and their SubtleMR™ software is already known for reducing MRI scan times by up to 60%. The newly cleared SubtleSYNTH™ complements this by eliminating the need for additional image acquisition time for synthetic STIR images, offering the potential to streamline workflows in medical imaging.

This breakthrough is expected to reduce the frequency of rescan due to motion artifacts, ease the workload on healthcare professionals, and ultimately enhance patient care. By speeding up the imaging process and maintaining high-quality results, SubtleSYNTH™ presents a win-win for both patients and medical practitioners.

Future Plans and Broader Applications

Subtle Medical has ambitious plans for the future of SubtleSYNTH™. The company recently received a $2.3 million NIH SBIR grant to further advance this technology. The goal is to expand its application to brain and musculoskeletal (MSK) imaging, which could open new doors for faster and more efficient diagnosis across various medical fields.

Chief Product Officer Ajit Shankaranarayanan expressed excitement over this development, emphasizing the potential for AI to revolutionize diagnostic imaging. He highlighted that the reduction in acquisition time to zero is a major leap forward in operational efficiency.

Improving Medical Imaging Workflows

Josh Gurewitz, Chief Commercial Officer at Subtle Medical, highlighted the broader implications of this FDA approval. According to Gurewitz, the software not only advances imaging quality but also helps simplify complex workflows for radiologists and technologists.

With SubtleSYNTH™, Subtle Medical aims to deliver this advanced tool to healthcare institutions, enabling them to achieve better outcomes in imaging speed, quality, and overall patient care. The company plans to showcase their new technology at RSNA 2024 and invites interested parties to explore its benefits through demos.

About Subtle Medical

Subtle Medical is a global leader in AI-powered medical imaging technology, aiming to make medical imaging faster, safer, and more intelligent. Recognized by CB Insights as a GenAI 50, Top AI 100, and Digital Health 150 company, Subtle Medical continues to push the boundaries of what's possible in healthcare technology.

Their innovative solutions, backed by solid research and development, are designed to optimize imaging workflows and improve both productivity and patient experiences. Visit subtlemedical.com to learn more about their groundbreaking technologies.