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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…
- Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA reviewCompass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging…STAT · 5d agoRegulatoryNeutral