The Meals and Drug Administration (FDA) has granted 510(ok) clearance for the SubtleSynth software program, a deep studying utility that gives artificial quick tau inversion restoration (STIR) photographs from current T1 and T2-weighted magnetic resonance imaging (MRI).1
Refined Medical, the developer of the SubtleSynth software program, stated there may be zero MRI acquisition time with the artificial STIR photographs.
The artificial STIR photographs generated with the newly FDA-cleared SubtleSynth software program, a complementary deep studying software program to Refined Medical’s SubtleMR software program, have been “diagnostically interchangeable” with conventionally acquired STIR photographs, based on the authors of a 2023 multicenter examine. (Photographs courtesy of Refined Medical.)
In a 2023 multicenter examine revealed within the American Journal of Neuroradiology, researchers discovered that the artificial STIR photographs generated with SubtleSynth, a complementary software program to Refined Medical’s SubtleMR software program, have been “diagnostically interchangeable” with conventionally acquired STIR photographs.2
“SubtleSynth represents a big development by decreasing acquisition time for a standard MRI sequence to zero, enhancing operational effectivity,” stated Ajit Shankaranarayanan, the chief product officer at Refined Medical. “We imagine this software program will supply substantial time financial savings for each new and current scanners, scale back the necessity for rescans as a consequence of movement artifacts, and ease the workload on radiologists and technologists, in the end enhancing affected person care.”
References
1. Refined Medical. Refined Medical receives FDA clearance for {industry} first AI-powered artificial imaging software program, SubtleSYNTH. PR Newswire. Out there at: https://www.prnewswire.com/news-releases/subtle-medical-receives-fda-clearance-for-industry-first-ai-powered-synthetic-imaging-software-subtlesynth-302198830.html . Revealed July 17, 2024. Accessed July 17, 2024.
2. Tanenbaum LN, Bash SC, Zaharchuk G, et al. Deep learning-generated artificial MR imaging STIR backbone photographs are superior in picture high quality and diagnostically equal to traditional STIR: a multicenter, multireader trial. AJNR Am J Neuroradiol. 2023;44(8):987-993.
