Subtle Medical Receives FDA-Clearance for Industry First AI-powered Synthetic Imaging Software, SubtleSYNTH™

Subtle’s new software is now available for clinical use in the US, further redefining the speed and quality of accelerated MRI

MENLO PARK, CA, July 17, 2024 — Subtle Medical, a leading healthcare technology company using AI to improve medical imaging, announced FDA clearance of their new AI driven software solution, SubtleSYNTH™, which uses deep learning (DL) to generate synthetic STIR images (SynthSTIR’s) from already-acquired T1 and T2 weighted contrasts.

SubtleSYNTH is complementary to Subtle’s FDA-cleared SubtleMR™ software, which enables accelerated image acquisition of up to 60% for MRI procedures on any vendor, make or model of scanner. SubtleSYNTH creates the synthetic STIR images with zero acquisition time and are interchangeable with conventionally acquired STIR images. It was validated for use in the spine using a demographically diverse study recently published in AJNR.

The company has plans to expand the technology to Brain and MSK imaging in future releases. Subtle Medical was recently awarded a $2.3 million NIH SBIR grant in 2023 to continue the expansion of the SubtleSYNTH technology. By using more data to enable even better quality and faster imaging, Subtle’s suite of imaging solutions will redefine what’s possible for the speed and quality of MRI imaging.

“As we continue to explore the evolving landscape of AI-based diagnostic imaging, our focus remains on developing innovative solutions that set us apart. SubtleSYNTH represents a significant advancement by reducing acquisition time for a common MRI sequence to zero, enhancing operational efficiency,” said Ajit Shankaranarayanan, Chief Product Officer at Subtle. “We believe this software will offer substantial time
savings for both new and existing scanners, reduce the need for rescans due to motion artifacts, and ease the workload on radiologists and technologists, ultimately improving patient care.”

“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,” expressed Josh Gurewitz, Chief Commercial Officer at Subtle. “With the attainment of FDA clearance, we mark a new era of MRI quality and efficiency. We will eagerly begin to deploy this valuable new tool to customers to help them realize maximum potential of improved quality and care.”

Meet with us at this year’s RSNA or to receive a demo and explore the benefits of SubtleSYNTH at your institution, contact our team today.

About Subtle Medical

Subtle Medical is a leading global provider of AI-powered technology for faster, safer and smarter medical imaging. It has been named a CB Insights GenAI 50 company and two time CB Insights Top AI 100 and Digital Health 150 company. The company’s cutting-edge solutions optimize imaging workflows, improving productivity and patient experience. By harnessing the power of artificial intelligence, Subtle Medical aims to revolutionize medical imaging and transform the future of healthcare. For more information, please visit subtlemedical.com or email sales@subtlemedical.com.

Media Contacts:
Josh Gurewitz
Chief Commercial Officer
925 922 2615
Josh@SubtleMedical.com