FDA clears AI platform for PET imaging enhancement and quantification
Microstructure Imaging Inc. has received FDA 510(k) clearance for a software platform designed to enhance neurological PET images using structural MRI.
MICSI-PET uses MRI guidance to denoise and apply super-resolution to PET images while preserving quantitative PET information. It supports amyloid, tau and FDG PET and provides automated Centiloid measurements for amyloid imaging and CenTauR measurements for tau imaging. The software also generates regional standardized uptake value ratios and z-scores comparing patient results with normative controls.
The clearance comes as molecular PET imaging’s role in evaluating neurodegenerative disease continues to grow. Amyloid and tau PET can provide information about the biological processes underlying conditions such as Alzheimer’s disease, while FDG PET unearths patterns of cerebral metabolism.
The enhanced visualization MICSI-PET offers could be particularly useful in borderline cases, according to Lawrence N. Tanenbaum, MD, a neuroradiologist and imaging technology advisor.
“The difference can be dramatic in borderline amyloid cases,” Tanenbaum said in an announcement. “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.”
Microstructure Imaging said MICSI-PET was developed and validated for use across PET and MRI systems from multiple vendors and generations of scanner hardware. The company's goal is for providers to be able to integrate the technology into existing clinical workflows without requiring new PET infrastructure.
The company also is pursuing further clinical validation of its technology, and it anticipates a $2.275 million Phase 2 Small Business Innovation Research award from the National Cancer Institute to support multicenter validation of an upcoming neuroimaging platform. That work will be conducted in collaboration with NYU Langone Health and Memorial Sloan Kettering Cancer Center. (Microstructure Imaging is a Y Combinator-backed NYU Langone Health spinoff.)
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.