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There are various descriptions of Digital Therapeutics (abbreviated DTx) in circulation. The newly published ISO Technical Report defines DTx and classifies this term in relation to related terms such as SaMD, SiMD and Medical Device. This provides clarity in specialist circles. The ISO short description for DTx is: “DTx products generate and deliver medical interventions that are based on clinical evidence, have a proven positive therapeutic impact on patient health and deliver real results.”

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