| Abstract: |
Artificial intelligence (AI) is already impacting the way we diagnose skin diseases. Although there are many new AI tools promoted to be helpful to dermatologists and primary care physicians, especially in the recognition of melanoma and nonmelanoma skin cancers, there is a major obstacle that the sponsoring companies must overcome before it is possible to integrate any of these innovative AI-enabled technologies into clinical practice. The regulatory process of the Food and Drug Administration (FDA) is demanding and requires proof of safety and effectiveness for each of these devices before the FDA gives their approval. Herein we discuss the reasons why there are hundreds of papers applying AI to imaging in dermatology, but the only available FDA-approved AI dermatology tools use spectroscopy. © 2025 Elsevier Inc. |
