IA como Dispositivo Médico para Imágenes Oftálmicas en Europa, Australia y los Estados Unidos: Protocolo para una Revisión de Escopeta Sistemática de Dispositivos Regulados.
PMID: 38483456 ·
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Resumen
Artificial intelligence as a medical device (AIaMD) has the potential to transform many aspects of ophthalmic care, such as improving accuracy and speed of diagnosis, addressing capacity issues in high-volume areas such as screening, and detecting novel biomarkers of systemic disease in the eye (oculomics). In order to ensure that such tools are safe for the target population and achieve their intended purpose, it is important that these AIaMD have adequate clinical evaluation to support any reg
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Fuente oficial
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