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Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective.
Andrzej Grzybowski, T Y Alvin Liu, Marko M Popovic, Ally Zhao, Masahiro Miyake, Hidenori Takahashi et al.
Asia Pac J Ophthalmol (Phila)May 20260 citationsReview
This review found ophthalmic AI device regulations vary globally, creating deployment hurdles. Aligned international standards are crucial for safe, equitable clinical use.