Microstructure Imaging's MICSI-PET Software Receives FDA Clearance to Enhance Neurological PET Imaging Using MRI

Microstructure Imaging's software platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The platform is designed to enhance neurological positron emission tomography (PET) images using structural magnetic resonance imaging (MRI).

The software, called MICSI-PET, can denoise and super-resolve PET images using MRI guidance while preserving quantitative PET information. It supports PET exams for amyloid, Tau, and FDG (fluorodeoxyglucose), and can provide automated Centiloid measurements for amyloid imaging and CenTauR measurements for Tau imaging. In addition, the software can generate regional standardized uptake value ratios (SUVRs) and Z-scores that compare patient results with a normative control group.

The clearance comes as molecular PET imaging plays an increasingly prominent role in evaluating neurodegenerative diseases. Amyloid and Tau PET can provide information about the biological processes underlying diseases such as Alzheimer's disease, while FDG PET can reveal brain metabolic patterns.

Lawrence N. Tanenbaum, MD, a neuroradiologist and imaging technology consultant, said the enhanced visualization provided by MICSI-PET may be particularly useful in borderline cases.

In the announcement, Tanenbaum noted that in borderline amyloid cases, this improvement could be game-changing. When physicians are trying to determine whether true cortical retention is present, MICSI-PET can make the imaging pattern much clearer. Adding automated quantification alongside improved image quality gives reading physicians a more powerful means of evaluating the exam.

Microstructure Imaging said the development and validation of MICSI-PET covered PET and MRI systems from multiple vendors and different hardware generations. The company's goal is to enable healthcare providers to seamlessly integrate the technology into existing clinical workflows without purchasing additional PET hardware.

The company is also currently seeking further clinical validation for its technology. In addition, it expects to receive a $2.275 million Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute to support upcoming multicenter validation of the neuroimaging platform. The study will be conducted in collaboration with NYU Langone Health and Memorial Sloan Kettering Cancer Center. A Y Combinator-backed company, Microstructure Imaging is a spinout from NYU Langone Health.