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PLoS One 2010;5:e15360

Given that a substantial amount of the novelty in modern medical devices lies on the algorithms that process the physiologic signals -as opposed to the hardware-, it would be advisable for the FDA to consider the nature of these algorithms (and their training sets) as part of their review of technological characteristics in order to determine whether differences between the algorithms in the devices raise different questions of safety and effectiveness

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L.KashiwagiJ.DwivediS

References Burke, O., Sa, B., Cespedes, D

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