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

Year: 2026

Type: article

Abstract: 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.

Source: npj Digital Medicine

DOI: 10.1038/s41746-026-02609-2

Authors: Oscar Freyer, Stephan Buch, Adel Bassily-Marcus, Sven Zenker, Brian W. Pickering, Max Ostermann, Anett Schönfelder, Stephen Gilbert

Institutions: Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Yale University, Yale New Haven Health System, University of Bonn, University Hospital Bonn, Institut für Medizinische Biometrie, Informatik und Epidemiologie, Mayo Clinic

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $4,090

Funders: European Commission, Bundesministerium für Bildung und Forschung, HORIZON EUROPE Framework Programme

Awards: G2656456574, SEMECO: Kl-assistierte Regulatorik für Medizin und Cybersecurity (Q2) - Teilvorhaben A, Enhanced cybersecurity for networked medical devices through optimisation of guidelines, standards, risk management and security by design

OpenAlex ID: W7153228686

FWCI:

Cites: 28

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