syngo.via MI Workflows; Scenium; syngo MBF

The syngo.via MI Workflows, including Scenium and syngo MBF, is a software system designed for advanced post-processing and quantitative analysis of multi-modality medical images (PET, CT, MR, NM) to support clinical decision-making in oncology, cardiology, neurology, and radiotherapy planning. Its scientific advancement includes the integration of Centiloid scoring for standardized amyloid PET quantification in neurology, validated through calibration against reference datasets and demonstrating strong correlation with established methods and clinical assessments.

syngo.via MI Workflows, incorporating Scenium and syngo MBF applications, is a software-only medical device for multi-modality image post-processing. It assists trained healthcare professionals by enabling viewing, manipulation, quantification, analysis, and comparison of medical images from PET, CT, MR, and nuclear medicine, across single or multiple time-points. The system, operating on a client/server architecture, supports disease management in oncology, cardiology, neurology, and organ function, aids in radiotherapy treatment planning, and can perform SUV harmonization for PET data across different systems or reconstruction methods. A key enhancement in the latest version is the implementation of Centiloid scoring within the Scenium neurology application (VE70), designed to standardize brain PET amyloid quantification for Amyvid™, Neuraceq™, and Vizamyl™ tracers. This feature was validated by calibrating PET images against reference data, achieving high correlation (R² values of 0.95-0.98) with established methods. Independent validation further confirmed strong agreement with ADNI Centiloid values, and the Scenium Centiloid scale demonstrated excellent agreement with visual readings in classifying Mild Cognitive Impairment patients, with an optimal cut-off identified. Other components like syngo.MM Oncology, syngo.MI General, and syngo MBF cardiology (VB30) maintain their existing functionalities.

AI Regulatory Concerns

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• Q1. How does the Centiloid scoring implementation in Scenium VE70 account for potential variations in image acquisition protocols or scanner calibrations across different clinical sites, beyond the three specifically validated tracers?; What is the clinical impact of the 26 Centiloid cut-off value in differentiating amyloid positivity, particularly in early or ambiguous cases of Mild Cognitive Impairment, and how does this compare to other quantitative amyloid PET analysis methods?; Could the SUV harmonization feature within syngo.via MI Workflows be extended to other radiotracers or quantitative metrics beyond PET SUV, and what are the validation requirements for such expansions?; Beyond the reported R-squared values, what were the specific limits of agreement or observed bias in the independent validation of Scenium's Centiloid scores against the ADNI pipeline for each of the three amyloid tracers?; How does the syngo.via MI Workflows platform handle and integrate longitudinal imaging data, especially for tracking disease progression or treatment response using the quantitative metrics it provides, such as Centiloid scores or harmonized SUVs?