The iRhythm Zio Patch was cleared by the FDA for use only by physician prescription using the 510(k) pathway as the product was deemed 'substantially equivalent' to predicate devices. We presented a ...
More than a decade after first earning the FDA’s sign-off for its Zio ECG patch, iRhythm is still churning out data to prove beyond a shadow of a doubt the heart monitor’s ability to spot atrial ...
From a technological standpoint, the miniaturization of the Holter monitor concept was long overdue. In the author's opinion, there is little, if any, clinical advantage of the Holter monitor over ...
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