NPJ Digit Med
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany.
Published: June 2024
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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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11180084 | PMC |
http://dx.doi.org/10.1038/s41746-024-01161-1 | DOI Listing |
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State Key Laboratory of Advanced Medical Materials and Devices, Tianjin Key Laboratory of Biomedical Materials, Key Laboratory of Biomaterials and Nanotechnology for Cancer Immunotherapy, Institute of Biomedical Engineering, Tianjin Institutes of Health Science, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300192, China.
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View Article and Find Full Text PDFBiomater Res
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Center for Plastic & Reconstructive Surgery, Department of Dermatology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou 310014, Zhejiang, China.
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View Article and Find Full Text PDFBMJ Open
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Wiser Healthcare Research Collaboration, Sydney, New South Wales, Australia
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BMC Cancer
January 2025
Department of Data Science, Faculty of Interdisciplinary Science and Technology, Tarbiat Modares University, Tehran, Iran.
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