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SimBioSys gets FDA clearance for AI breast-cancer recurrence tool

The FDA cleared an AI tool that estimates breast cancer recurrence risk using imaging, pathology, and clinical data.

1 min read
HealthcareInsuranceProduct developmentScience and research

SimBioSys has received FDA clearance for TumorSight Risk, an artificial intelligence tool designed to estimate the risk of breast cancer recurrence. The software combines imaging, pathology, and clinical data to generate its risk score.

The clearance is supported by retrospective validation results. The tool is intended to be used by clinicians alongside established evidence and professional judgment, not as a standalone determinant of patient outcome.

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