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Article History

Received: 21 February 2025

Accepted: 25 February 2025

First Online: 18 March 2025

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. R.M. declares no nonfinancial interests and no competing financial interests. S.G. declares a nonfinancial interest as an Advisory Group member of the EY-coordinated "Study on Regulatory Governance and Innovation in the field of Medical Devices" conducted on behalf of the DG SANTE of the European Commission. S.G. declares the following competing financial interests: he has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd., Flo Ltd, ICURA ApS, Rock Health Inc., Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, DG SANTE, Prova Health Ltd, Haleon plc and Ada Health GmbH and holds share options in Ada Health GmbH. S.G. is a News and Views Editor for npj Digital Medicine. S.G. played no role in the internal review or decision to publish this News and Views article.