Venkatesh Kaushik P, Kadakia Kushal T, Gilbert Stephen
Harvard Medical School, Boston, MA, USA.
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany.
NPJ Digit Med. 2024 Jun 15;7(1):156. doi: 10.1038/s41746-024-01161-1.
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.
美国食品药品监督管理局（FDA）最近批准了DermaSensor，这是一款用于基层医疗中皮肤癌检测的人工智能设备，标志着数字健康创新的一个关键时刻。在临床上，首款由非专科医生使用的用于检测皮肤癌的人工智能设备的获批，强化了数字健康技术弥合医疗实践中获取渠道和专业知识差距的可行性。该批准还为FDA批准皮肤科领域采用人工智能和机器学习（ML）技术的医疗设备树立了新的监管先例。本文将结合DermaSensor的批准情况，探讨皮肤科领域新兴人工智能技术的临床证据和监管影响。
