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QMENTA Neuroimaging Platform

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(1)5.0/5

QMENTA is the AI orchestration platform for regulated medical imaging in clinical trials and research. Designed specifically for imaging-intensive multi-site studies, the platform connects scanners, sites, AI models, and regulators into a single auditable system — compressing trial timelines and eliminating operational imaging risk.The platform covers the complete imaging workflow: cloud-based site activation with no IT setup, real-time QC and protocol adherence monitoring, vendor-neutral harmonisation across scanner manufacturers, governed AI deployment with version-locked and audit-trailed algorithms, zero-footprint central review for all stakeholders, and automated regulatory closeout documentation. The full chain of custody from first scan to submission lives in one system.QMENTA is 510(k)-cleared by the FDA, compliant with FDA 21 CFR Part 11, HIPAA, GDPR, ISO 13485, and GxP standards, and has achieved zero nonconformities across all external pharmaceutical partner audits. The platform supports more than 90 validated imaging AI workflows and biomarker tools, is vendor-neutral across GE HealthCare, Siemens Healthineers, Philips, Canon, and any DICOM system, and is deployable on GCP, AWS, or Azure.QMENTA is in production across more than 400 imaging sites, with over 16 million imaging files processed and 1.3 million subjects across clinical trials, academic medical centres, and biopharma programmes. Customers include Cleveland Clinic, Cedars-Sinai, Harvard Medical School, UCSF, Bayer, ICON, and Parexel. The platform served as the operational backbone for the CAVS-MS trial, which validated Central Vein Sign biomarkers and contributed to revising the McDonald Criteria — the global diagnostic standard for Multiple Sclerosis.

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