MICSI wins FDA clearance for MR-guided PET brain imaging software

Microstructure Imaging said it received FDA 510(k) clearance for MICSI-PET, software that uses MRI to guide PET image enhancement while keeping quantitative PET data, and automatically reports amyloid Centiloid and tau CenTauR measures used in neurological imaging.

Same-day HEALTH primary that FDA cleared AI-powered neurological PET software meant to make amyloid and tau scans clearer and automatically scored — the lane clinics use when evaluating Alzheimer’s-related imaging.

Microstructure Imaging, Inc. (MICSI), a Y Combinator-backed NYU Langone Health spinout, announced via Business Wire on 15 Sep 2026 that it received FDA 510(k) clearance for MICSI-PET. The release is titled “Microstructure Imaging Receives FDA Clearance for MICSI-PET, Bringing MR-Guided Enhancement and Automated Quantification to Neurological PET,” datelined NEW YORK, newsitem 20260915804417, and carried the same day on Business Wire partners including BioSpace. A 510(k) is the common FDA path that clears a device as substantially equivalent to something already on the market. This is software clearance — not a new PET scanner and not a drug approval. That company PRIMARY via Business Wire is the filing event. These are company claims. This desk did not review the FDA letter.

Company framing on the same wire: MICSI-PET is the first FDA-cleared MR-guided PET enhancement software with automated amyloid Centiloid and tau quantification. File “first” as the company’s statement — not as an independent rank this desk can certify. This desk did not survey every cleared PET tool.

What the software is designed to do, as the company tells it: use structural MRI — magnetic resonance imaging, a detailed anatomy scan — to guide PET denoising and super-resolution. PET is positron emission tomography, a nuclear-medicine brain scan that maps where a tracer goes. Denoising means cleaning grain from the image. Super-resolution means trying to sharpen a lower-detail scan. The company says that produces higher-quality PET images while maintaining quantitative PET information — the numbers used to measure tracer uptake, not just a prettier picture. The platform also automatically reports Centiloid scores for amyloid PET and CenTauR scores for tau PET, plus regional SUVr measurements and z-scores compared with normative controls. Amyloid and tau are proteins tracked in Alzheimer’s-related imaging. Centiloid and CenTauR are standardized scores so those PET results can be compared across scanners. SUVr is standardized uptake value ratio, a common PET measurement. A z-score says how far a result sits from a typical control group. File that job as the company’s. This is assist software, not a diagnosis on its own and not a claim it replaces radiologists or cures Alzheimer’s.

Modalities supported, still company: amyloid, tau, and FDG PET. FDG is a common PET tracer used to watch brain metabolism — how the brain uses sugar. The company says MICSI-PET was developed and validated for real-world deployment across PET and MRI systems from major vendors and multiple generations of scanner hardware. File those tracers and that multi-vendor / multi-generation line as MICSI’s. This desk did not sit on a scanner.

Workflow, as the same wire has it: MICSI-PET integrates into existing clinical imaging workflows, adding MR-guided enhancement and automated quantification to existing PET infrastructure. File that integrate-into-existing-kit pitch as the company’s. This desk did not watch a hospital install.

Named voice on the release: Lawrence N. Tanenbaum, MD, FACR, neuroradiologist and imaging technology advisor, who argues the difference can be dramatic in borderline amyloid cases and that automated scores plus clearer images give the reader a more powerful way to evaluate the exam. File the name and title as the company’s. His quotes are color only and stay in Sources.

Company background, still MICSI’s: Microstructure Imaging develops software for medical image enhancement and quantitative analysis. It is an NYU Langone Health spinout backed by Y Combinator. Named contact on the wire: Gregory Lemberskiy, PhD, chief executive. File those lines as the company’s. This filing is not a product review of the company’s earlier MRI-enhancement software.

Forward-looking only, as the wire states it: MICSI says it 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 with NYU Langone Health and Memorial Sloan Kettering Cancer Center. SBIR is the U.S. Small Business Innovation Research grant program. File $2.275 million, Phase II, NCI, and those two hospital names as an anticipated company statement — not as a closed grant receipt. The wire says “anticipating,” not “received.”

Plain English for the rest of the card: PET = positron emission tomography, a nuclear-medicine brain scan. MRI = magnetic resonance imaging, a detailed anatomy scan. 510(k) = FDA clearance path for a device substantially equivalent to one already cleared. Centiloid / CenTauR = standardized scores so amyloid and tau PET results can be compared across scanners. FDG = a common PET tracer for brain metabolism. SUVr = standardized uptake value ratio. z-score = how far a result sits from a typical control group. SBIR = Small Business Innovation Research, a U.S. grant program.

What this is not: MICSI-PET is software clearance for image enhancement and automated scores — a helper for neurological PET reads, not a new scanner, not a drug approval, not De Novo, and not a claim it cures Alzheimer’s or replaces a radiologist. This desk is not inventing a 510(k) number, a sensitivity or specificity percentage, a trial N, or clinical-trial endpoints the wire does not print.

PRIMARY here: Microstructure Imaging’s 15 Sep 2026 Business Wire company announcement — Tier A company source, the original record, newsitem 20260915804417 — plus the same-day BioSpace / Business Wire syndicate reprint used to read the company text after the businesswire.com URL can sit behind a wire interstitial. The company site is product-home context, not a second originating newsroom. The 510(k) clearance, the MR-guided PET enhancement plus automated amyloid Centiloid and tau CenTauR job, the “first” company claim, the amyloid / tau / FDG support, the multi-vendor validation line, the Y Combinator / NYU Langone spinout identity, the Tanenbaum title, and the anticipated $2.275 million Phase II SBIR are company-attributed. The “first” line and the SBIR stay company-attributed; the SBIR is anticipated, not a closed receipt. NOT claimed: a 510(k) number, De Novo, a new scanner or drug approval, sensitivity or specificity percentages, a trial N, that the SBIR is already awarded, that MICSI-PET cures Alzheimer’s or replaces a radiologist, that this desk reviewed the FDA letter, a stock tip, or investment advice. Distinct from the already-filed kairon-health-5m, powerful-medical-queen-of-hearts-fda-de-novo, azmed-azchest-fda-6th, nvidia-chop-cardiac-monai, and curvebeam-ai-fda-ct-bmd-510k.