FDA cleared MICSI-PET, software that borrows a patient's structural MRI to clean up their PET scan. Microstructure Imaging announced the 510(k) on September 15. The Brooklyn company, a spinout of NYU Langone Health backed by Y Combinator, says it is the first MR-guided PET enhancement software the agency has cleared.
The software denoises and super-resolves the PET image while holding the quantitative values steady, then reports amyloid Centiloid and tau CenTauR numbers, regional SUVr and z-scores against a normative control group. Amyloid, tau and FDG studies are all in scope. Preserving quantification is the hard part: an enhancement step that shifts SUVr is worse than no enhancement at all.
This is the second clearance built on the same denoising core. MICSI-RMT, which applies random matrix theory to diffusion and functional MRI, cleared under K241121 in July 2024. Slicing one platform algorithm into separate submissions by modality is a workable way for a small imaging company to keep its predicate arguments narrow.
The company also expects a $2.275M Phase II SBIR award from the National Cancer Institute to run multi-center clinical validation.