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- 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…
- Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumpsCapricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…