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. 2024 Jun 15;7(1):156.
doi: 10.1038/s41746-024-01161-1.

Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA

Kaushik P Venkatesh  1 , Kushal T Kadakia  1 , Stephen Gilbert  2
Affiliations

Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA

Kaushik P Venkatesh et al. NPJ Digit Med. .

Abstract

The U.S. Food and Drug Administration’s (FDA) recent authorization of DermaSensor, an AI-enabled device for skin cancer detection in primary care, marks a pivotal moment in digital health innovation. Clinically, the authorization of the first AI-enabled device for use by non-specialists for detecting skin cancer reinforces the feasibility of digital health technologies to bridge gaps in access and expertise in medical practice. The authorization also establishes a new regulatory precedent for FDA authorization of medical devices incorporating AI and machine learning (ML) technologies within dermatology. Together, this article uses the DermaSensor authorization to examine the clinical evidence and regulatory implications of emerging AI-enabled technologies in dermatology.

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Conflict of interest statement

K.P.V. declares no nonfinancial interests and no competing financial interests. K.T.K. reports fees from the Common Health Coalition (through ChangeLab Solutions) and the Journal of the American College of Cardiology, all unrelated to this manuscript. 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., Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, 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.

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