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Archimydes

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As per the FDA If you even simply acquire medical images, signals, or patterns - and don't even process or analyze them - you are classified as Software as a Medical Device (SaMD) as opposed to Clinical Decision Support (CDS) software. The guidance below provides a good framework for anyone considering building Healthcare related software for the US market. Essentially all of the following four criteria listed below have to be met for the FDA to consider your software CDS vs. a SaMD. In particular the software: 1) CANNOT acquire, process, or analyze medical images, signals, or patterns. 2) Can display, analyze, or print medical information normally communicated between health care professionals (HCPs). 3) Can provides recommendations (information/options) to a HCP rather than provide a specific output or directive. 4) Can provide the basis of the recommendations so that the HCP does not rely primarily on any recommendations to make a decision. You can read the full guidance provided by the FDA here: https://lnkd.in/e5N4DBNW #DigitalHealth #HealthcareAI #TechBio #TechMed #MedTech

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