iRhythm secures 510(k) clearance for Zio device updates after FDA warning

By Yahoo! Finance | Oct 22, 2024 at 07:48 AM EST

iRhythm Technologies received FDA clearance for design updates to its Zio AT device, a continuous monitoring system combining an ECG patch and AI-powered software. Despite previous FDA warning letters, the company is working on addressing compliance issues.

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