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- SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrenceSimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
- FDA issues warning letters to manufacturers over CGMP and GLP violationsThe U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…