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Article History

Received: 2 October 2024

Accepted: 22 August 2025

First Online: 10 September 2025

Declarations

:

: The need for ethics approval by an ethics committee or IRB was deemed unnecessary according to section 17 of the MDCG 2021–6 rev.1. This study, conducted in a simulated ICU setting, involved only artificial patient data for software testing and focused on evaluating the software’s usability and perceptions on its potential integration into existing workflows. The internal assessment of this usability study did not identify relevant risks for the users (software running on standard IT equipment). Thus, no relevant risk exposure for the participants according to section 17 of the MDCG 2021–6 rev.1 has been assessed and, consequently, this research is not considered a clinical investigation according to Article 2(45) of the MDR. Since the study focused on technical interactions between healthcare professionals and the software, no relevant risks for the participating healthcare professionals had been identified from the use of the software with standard IT equipment in a prior assessment, and the study did not include real patient data, direct patient care, clinical outcomes, or biomedical research on humans, ethical approval was not required. Clinical trial number: not applicable. Written informed consent was obtained from all participants (i.e., physicians and nurses) for compliance with data protection regulations.

: Not applicable.

: L.-M. Kunz; R. Pohlmeier and J. Petrovic Vorkapic are employees of Fresenius Medical Care. The remaining authors declare no commercial or financial conflict of interest.