FDA Clears Software That Combines MRI Enhancement of PET Imaging with Automated Quantification of Amyloid and Tau PET

The Food and Drug Administration (FDA) has granted 510(k) clearance for the MICSI-PET software, which reportedly facilitates enhanced image quality and provides automated quantification for tau and amyloid positron emission tomography (PET) scans.

Microstructure Imaging (MICSI), the developer of MICSI-PET, said the software offers the following key attributes:

• incorporation of structural MRI to enable denoising of PET images and improved image quality;

• automated Centiloid quantification for amyloid PET;

• automated CenTauR quantification for tau PET; and

• comparison of regional SUVr measurements and z-scores with normative controls.

“The difference can be dramatic in borderline amyloid cases,” noted Lawrence N. Tanenbaum, MD, FACR, a 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.”