Subtle Medical, the global leader in AI-powered medical imaging enhancement, has officially secured FDA’s clearance for its Subtle-HD™ solution, which happens to be the industry’s most advanced MRI acceleration and enhancement software till date.
According to certain reports, the stated approval will now allow for the launch of Subtle-ELITE™, a first-to-market AI-powered suite comprising of three software tools i.e. SubtleHD™, SubtleSYNTH™, and SubtleALIGN™, each solution meticulously designed to improve image quality and reduce MRI scan times by as much as 80%.
Taking a more specific view of these innovations, we begin from SubtleHD. The stated software arrives on the scene bearing an ability to leverage advanced denoising and sharpening, producing ultra-clear images that often exceed standard-of-care quality. Furthermore, it can facilitate comprehensive scans of all body regions.
Next up, we have SubtleSYNTH, a solution which banks upon deep learning to generate MR imaging contrasts from existing sequences, achieving 100% acceleration and producing STIR images in 0 minutes. While the software is only available for spine STIR at the moment, Subtle Medical is already working to accommodate other body regions in the near future.
Moving on to SubtleALIGN, it can automatically align brain MR to ideal anatomical position with 97%+ accuracy, thus reducing variability and improving consistency across longitudinal studies. The technology in question currently supports 3D brain sequences with the option to generate orthogonal reformats.
Talk about what the Subtle-ELITE suite offers from a collective standpoint, the highlights, like we briefly touched upon, include a promise to deliver faster and more efficient brand of imaging.
Next up, there is the potential for higher patient throughput and operational AI. The brand-new suite will achieve this by allowing imaging centers to add new slot times to serve more patients without any extra equipment investments.
“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,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. “By combining SubtleHD, SubtleSYNTH, and SubtleALIGN into a single, comprehensive package, Subtle-ELITE™ is setting a new benchmark for the future of MRI.”
Another detail worth a mention here is rooted in the availability of superior patient experience, something which makes it possible for hospitals and imaging institutions to reduce the time spent in the scanner, and therefore, scale up patient comfort by a significant margin.
Among other things, Subtle-ELITE suite delivers at your disposal vendor-neutral compatibility. We get to say because the assortment can work alongside all MRI scanners, regardless of manufacturer or model.
Rounding up the list of highlights would be the suite’s ability to extend your scanner’s lifespan. This stems from how the innovations in question can virtually upgrades existing MRI scanners and delay costly capital expenditures.
Founded in 2017, Subtle Medical’s rise up the ranks stands upon its AI-powered imaging solutions that are all designed to enhance the efficiency, quality, and accessibility of medical imaging. The company’s excellence in what it does can be understood once you consider it has already been recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company.
