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- FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detectionLantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits. The clearan…
- How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and MedicineAs AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…