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- FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reportsThe FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
- 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…Fierce Biotech · 5d agoRegulatoryPositive