Image-Based Cancer Prognostic Modelling
AI analysis of routine diagnostic imaging extracts tumour features that predict recurrence risk and treatment outcomes, enabling non-invasive prognostic assessment that previously required tissue biopsy and genomic assays.
Developed mainly in: United StatesImpacting: North America and Europe
SimBioSys received FDA 510(k) clearance for TumorSight Risk, software that combines breast MRI scans with pathology and clinical variables to estimate five- and ten-year recurrence probabilities in women with HR+, HER2-negative stage I-IIIA disease. It is described as the first imaging-derived recurrence risk tool to clear the agency.
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16 October 2026 · score 6.0/10
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Tracked from 2 signals, each traced to its source.
- FDA clears AI tool predicting breast cancer recurrence from MRI imaging data
Diagnosticimaging · 17 Oct 2026
- FDA clears AI system estimating breast cancer recurrence risk from MRI scans
Prnewswire · 16 Oct 2026
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