Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.

Nicholas PetrickWeijie ChenJana Gut Delfino Brandon D GallasYanna KangDaniel KrainakBerkman SahinerRavi K Samala

Published in: Journal of medical imaging (Bellingham, Wash.) (2023)

FDA's AI/ML regulatory and scientific efforts support the joint goals of ensuring patients have access to safe and effective AI/ML devices over the entire device lifecycle and stimulating medical AI/ML innovation.

Keyphrases

artificial intelligence
end stage renal disease
healthcare
ejection fraction
transcription factor
newly diagnosed
chronic kidney disease
machine learning
high resolution
peritoneal dialysis
deep learning
public health
patient reported outcomes
global health