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Article History

Received: 17 March 2026

Accepted: 13 May 2026

First Online: 19 May 2026

Competing interests

: T.D. declares no competing financial interests and a nonfinancial interest as a member of multiple study teams using LumineticsCore from Digital Diagnostics and as co-lead of Johns Hopkins University’s Bloomberg Distinguished Professorship Cluster on Global Advances in Medical Artificial Intelligence. T.D. is an Editor for npj Digital Medicine. T.D. played no role in the internal review or decision to publish this News and Views article. S.G. is an advisory group member of the Ernst & Young-coordinated “Study on Regulatory Governance and Innovation in the field of Medical Devices” conducted on behalf of the Directorate-General for Health and Food Safety of the European Commission. S.G. has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd, Flo Ltd, Thymia Ltd, FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, and Ada Health GmbH, and the Saudi Arabia Food and Drug Authority (FDA) funded through the United Nations Development Programme (UNDP), and he holds share options in Ada Health GmbH. S.G. is a News and Views Editor for npj Digital Medicine, but is not part of the peer review process or decision-making of this manuscript. S.G. played no role in the internal review or decision to publish this article.