510(K) approval for vision App by the FDA. Our new world treats medical Apps as medical devices, needing approval. Britain’s NICE is effectively doing this by accreditation and approval stamping, but inevitably, it will move towards formal approval based on clinical evidence. This is fine: it creates discipline and rigor in an industry famous for launching flaky products full of bugs and subsequent patches. It is a sign of a maturing industry. ”
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http://optometrytimes.modernmedicine.com/optometrytimes/news/iphone-app-vision-tests-wins-fda-approval