In the author's opinion, there is little, if any, clinical advantage of the Holter monitor over newer technologies such as the Zio Patch. Once the reimbursement hurdles are overcome, it is ...
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 ...
GlobalData on MSN4 个月
iRhythm secures 510(k) clearance for Zio device updates after FDA warningThe Zio AI continuous monitoring system combines a wearable electrocardiogram (ECG) patch, named the Zio AT patch, with the ...
Zacks.com on MSN4 个月
iRhythm Technologies Stock Rises Post FDA Clearance for Zio ATIt includes the Zio AT patch, which records ECG data for up to 14 days, and a wireless gateway that transmits data to iRhythm ...
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