Subtle Medical’s AI-Powered Synthetic Imaging Software Gets FDA Clearance

Subtle Medical has received FDA clearance for their new 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 synthetic STIR images with zero acquisition time that are interchangeable with conventionally acquired STIR images. It was validated for use in the spine using a demographically diverse study recently published in AJNR.

Subtle Medical was recently awarded a $2.3 million NIH SBIR grant in 2023 to continue the expansion of the SubtleSYNTH technology. The company has plans to expand the technology to brain and MSK imaging in future releases.  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 Medical. "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 Medical. "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."