Is Your AI-enabled Smartphone App a Medical Device?
Are you aware some AI-enabled health apps need FDA clearance? Learn the difference between regulated and wellness apps. Read more and share!
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Subok Park, PhD
Jan 29
From concept to reality: Ensuring clinical relevance and regulatory fit for ai-enabled Software as a Medical Device (SaMD)
AI SaMDs can transform healthcare, but misaligned clinical and regulatory strategies cause delays. Learn how early alignment drives success!
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