FDA Clears Innovative MR-guided PET Software for Neurological Imaging

Microstructure Imaging, Inc. (MICSI) has received FDA 510(k) clearance for its MICSI-PET software platform, which provides a significant enhancement to neurological PET imaging through MR-guided PET enhancement and automated quantification for amyloid and tau.

The innovative platform utilizes structural MRI to enhance PET images, offering improved denoising and super-resolution, while maintaining essential quantitative PET data. It includes automated Centiloid quantification for amyloid PET and CenTauR quantification for tau PET, in addition to providing regional standardized uptake value ratios (SUVr) measurements and z-scores compared with a normative control database.

Approved by the FDA, the MICSI-PET platform is compatible with amyloid, tau, and FDG PET scans. It has been developed and validated for deployment across a range of PET and MRI systems from different manufacturers, compatible with various generations of scanner hardware.

According to Dr Lawrence N. Tanenbaum, a neuroradiologist and imaging technology advisor, “the difference can be dramatic in borderline amyloid cases," highlighting the platform's ability to improve visualization, which aids in assessing cortical sparing. Combining enhanced visualization with automated quantification provides clinicians a robust tool for evaluating neurological examinations.

MICSI-PET is designed to integrate seamlessly into existing clinical imaging workflows, providing MR-guided enhancements and automated quantification within the current positron emission tomography infrastructure.

Looking ahead, MICSI aims to secure a $2.275 million Phase II SBIR award from the National Cancer Institute. This funding is intended to support a multi-center clinical validation of its upcoming neuroimaging platform in collaboration with prestigious institutions such as NYU Langone Health and Memorial Sloan Kettering Cancer Center. This development signifies forward momentum in the integration of advanced imaging technologies in the clinical environment.