MICSI Wins FDA Clearance for Brain PET Software
MICSI (micsi.co) has received FDA 510(k) clearance for MICSI-PET, software that uses a patient's structural MRI to improve the quality of brain PET scans and automatically measures the amyloid and tau proteins associated with Alzheimer's disease. The company, an NYU Langone Health spinout that went through Y Combinator's Summer 2023 batch and was backed at seed by Pioneer Fund, announced the clearance on Tuesday.
The product applies MR-guided denoising and super-resolution to PET images while preserving the quantitative information radiologists rely on. It handles amyloid, tau and FDG PET, and was validated for deployment across PET and MRI systems from major vendors and several generations of scanner hardware, so sites can add it to the equipment they already own instead of buying a new scanner.
MICSI was co-founded by CEO Gregory Lemberskiy, whose PhD work covered algorithm development for image enhancement and biophysical modeling of the MRI signal, and Benjamin Ades-Aron, who earned an NYU PhD in electrical engineering with a focus on machine learning methods for visualizing MRI data. This is the company's second clearance: its first product, MICSI-RMT, a random matrix theory approach to MRI denoising, was cleared in July 2024.
"The difference can be dramatic in borderline amyloid cases. When you're trying to determine whether there is true cortical sparing, MICSI-PET can make the pattern substantially easier to see."
Lawrence N. Tanenbaum, MD, neuroradiologist and imaging technology advisorInterpreting brain PET is hardest at the margins, where a reader has to decide whether a faint pattern is real. Pairing a cleaner image with objective numbers is the case MICSI is making to radiologists, and it is the same argument the company used for its MRI product: better output from installed hardware rather than a hardware replacement cycle.
"Brain scans are not always easy to interpret, especially in borderline cases. A clearer image, paired with objective measurements, gives physicians more confidence, and MICSI-PET works with the scanners hospitals already have."
Dave Messina, General Partner at Pioneer Fund's Future of Health fundMICSI is also anticipating a $2.275 million Phase II SBIR award from the National Cancer Institute to fund multi-center clinical validation of a forthcoming neuroimaging platform, work it plans to carry out with NYU Langone Health and Memorial Sloan Kettering Cancer Center.