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Authorization of prognostic AI medical devices

Nature Machine Intelligence volume 8, pages 138–143 (2026) Cite this article

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Less than 2% of artificial intelligence devices authorized by the US Food and Drug Agency are prognostic, with prediction horizons ranging from minutes to several years. As the number of prognostic AI devices could increase, it is important to address the accompanying regulatory and ethical challenges.

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Fig. 1: Authorized prognostic AI/ML-enabled medical devices by specialty and year.
The alternative text for this image may have been generated using AI.
Fig. 2: Prediction horizons of authorized prognostic AI/ML-enabled medical devices.
The alternative text for this image may have been generated using AI.

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Authors and Affiliations

  1. Department of Nuclear Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland

    Urs J. Muehlematter

  2. Academic Chair for Regulaion in Law, Medicine and Technology, Faculty of Law, University of Zurich, Zurich, Switzerland

    Kerstin Noelle Vokinger

  3. Academic Chair for Regulation in Law, Medicine and Technology, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland

    Kerstin Noelle Vokinger

Authors
  1. Urs J. Muehlematter
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  2. Kerstin Noelle Vokinger
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Correspondence to Urs J. Muehlematter.

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The authors declare no competing interests.

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Muehlematter, U.J., Vokinger, K.N. Authorization of prognostic AI medical devices. Nat Mach Intell 8, 138–143 (2026). https://doi.org/10.1038/s42256-025-01171-y

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