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FDA approvals can greatly increase investor confidence and stock value, as seen in past cases where medical device companies surged post-approval.
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FDA approved iRhythm's 510(k) submission for Zio AT device. Zio AT device remains available for shipping in the U.S. Management expects second approval soon, possibly by October. Analysts view updates positively, indicating progress in FDA alignment. Enhanced telemetry technology may improve competitive position.
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