MOBILE HEALTH APPS are in the FDA spotlight after a urine test App was told it would need a 510(k) approval, and other Apps measuring vital signs are in limbo. The UK’s NHS has set its stamp of approval for safety on 70 of some 13,000 Apps worldwide. In January 2012 the first UK CE Mark was issued for a health App. It seems most unlikely that regulatory approval will be circumvented by Apps for medical measurements or diagnosis ranging from diabetes to hearing loss.
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linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022