The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units

Artificial intelligence (AI) is increasingly used in healthcare, yet translation into routine intensive care units (ICU) practice remains slow. Through a multimethod search, we identified 36 on-market ICU-specific AI-enabled medical devices in the US and EU, challenging previous research findings. Most devices focus on prediction. However, as availability does not equal proven benefit, adoption will depend less on the availability of additional models and more on addressing persistent implementation barriers.