Microstructure Imaging Receives FDA Clearance for MICSI-PET, Bringing MR-Guided Enhancement and Automated Quantification to Neurological PET

First FDA-cleared MR-guided PET enhancement software, with automated amyloid Centiloid and tau quantification

NEW YORK--(BUSINESS WIRE)--Microstructure Imaging, Inc. (MICSI), a Y Combinator-backed NYU Langone Health spinout, has received FDA 510(k) clearance for MICSI-PET, a neurological PET software platform combining MR-guided PET enhancement with automated amyloid and tau quantification.

MICSI-PET uses structural MRI to guide PET denoising and super-resolution, producing higher-quality PET images while maintaining quantitative PET information. The platform provides automated Centiloid quantification for amyloid PET and CenTauR quantification for tau PET, along with regional SUVr measurements and z-scores compared with normative controls.

MICSI-PET supports amyloid, tau and FDG PET and was developed and validated for real-world deployment across PET and MRI systems from major vendors and multiple generations of scanner hardware.

“The difference can be dramatic in borderline amyloid cases,” said Lawrence N. Tanenbaum, MD, FACR, neuroradiologist and imaging technology advisor. “When you’re trying to determine whether there is true cortical sparing, MICSI-PET can make the pattern substantially easier to see. Adding automated quantification to that improved visualization gives the reader a much more powerful way to evaluate the examination.”

MICSI-PET integrates into existing clinical imaging workflows, adding MR-guided enhancement and automated quantification to existing PET infrastructure.

Building on this clinical momentum, MICSI is anticipating a $2.275 million Phase II SBIR award from the National Cancer Institute to support multi-center clinical validation of its upcoming neuroimaging platform in collaboration with NYU Langone Health and Memorial Sloan Kettering Cancer Center.

About Microstructure Imaging

Microstructure Imaging, Inc. develops software for medical image enhancement and quantitative analysis. MICSI is an NYU Langone Health spinout backed by Y Combinator.

For more information, visit www.micsi.com or email [e-mail].