AI-enabled medical device

AI-enabled medical device

                                                Medical AI & Bioinformatics; Human-centered AI

noun phrase

Definition: A medical device that incorporates an AI-enabled software function or other AI capability to perform or support a medical purpose, such as analysis, monitoring, diagnosis, prediction, or clinical decision support [IMDRF].

Example in context: “Availability of quality data is a key factor in determining clinical utility of an AI-enabled medical device …” [Samala et al. 2025]

Synonyms: AI/ML-enabled medical device; AI-enabled healthcare device

Related terms: AI-enabled device software function; machine-learning-enabled medical device; software as a medical device (SaMD); clinical decision support