Microstructure Imaging (MICSI) has received clearance from the U.S. Food and Drug Administration (FDA) for MICSI-PET, a neurological PET software platform that uses structural MRI to guide PET image enhancement and automated quantitative analysis.
The platform is cleared across F-18 FDG, amyloid (florbetapir, florbetaben, flutemetamol), and tau (flortaucipir) radiotracers and includes the following capabilities:
MRI-guided super-resolution and denoising, cleared for diagnostic use
Automated Centiloid quantification for amyloid PET and CenTauR quantification for tau PET
Regional standardized uptake value ratio (SUVr) measurements and z-scores compared with normative controls
Integrated quality control for coregistration, segmentation, super-resolution, and quantitative analysis
MICSI-PET is the first FDA-cleared MRI-guided PET software and includes the first FDA-cleared implementation of CenTauR for tau PET quantification, according to the company. It integrates into existing clinical workflows across PET and MRI systems from major vendors, the firm said.
MICSI’s previous clearances include for MICSI-RMT, image enhancement software for brain MRI. The company is a spinoff of NYU Langone Health.
