iRhythm Technologies, a manufacturer of cardiac monitoring systems, has received its second FDA 510(k) clearance for design modifications and labeling updates to its Zio AT wearable cardiac monitoring system. This clearance comes a week after the first 510(k) clearance for design modifications.
To strengthen its quality management system, iRhythm has expanded its regulatory and quality staff from 20 to over 100 employees, hired a new quality management leader, and partnered with a consulting firm for internal audits. The company has also postponed its FDA submission for the next-generation Zio MCT device to Q3 2025, with launch expected in 2026.
Analyst QuickTake: In May 2023, the FDA issued a warning letter to iRhythm Technologies, highlighting serious compliance issues regarding its Zio AT mobile cardiac telemetry device. The recent clearance addresses design modifications and required labeling updates regarding manufacturing facility issues this warning letter highlights.
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