iRhythm Technologies has secured 510(k) clearance from the Food and Drug Administration (FDA) for design modifications to its Zio AT wearable cardiac monitoring system. This clearance addresses issues raised in a prior warning letter concerning the company's manufacturing facility. The approval encompasses both design modifications and updates to the device's labeling.
The announcement, made during iRhythm's recent earnings call, follows a previous 510(k) clearance for other design modifications to the Zio AT device. The Zio AT system is a wireless patch monitor that continuously records ECG data for up to 14 days, aiding in the diagnosis of various cardiac arrhythmias.
Delay in Next-Generation Device Submission
Quentin Blackford, CEO of iRhythm, also announced the decision to delay the FDA submission for the next-generation Zio MCT device until the third quarter of 2025, with a commercial launch anticipated in 2026. This delay is intended to allow the company to ensure the thoroughness of the submission and address potential agency questions proactively.
Remediation Efforts and Quality Management
The FDA's warning letter to iRhythm in 2023 followed a facility inspection that revealed issues, including unauthorized changes to the Zio system and marketing it for a new, high-risk patient population. In response, iRhythm is expanding its remediation efforts beyond the specific focus of the warning letter.
"We are rebuilding our entire quality management system, touching every aspect of it, including areas that have not been part of the FDA's recent inspections with the intent of making our quality system truly best in class," said Blackford.
As part of these efforts, iRhythm has significantly increased its regulatory and quality staff, from 20 employees two years ago to over 100. The company has also appointed a new quality management leader and is collaborating with a consulting firm to conduct internal audits of its quality system.
Financial Performance
iRhythm reported an 18% year-over-year increase in third-quarter revenue, reaching $147.5 million. However, the company also reported a net loss of $46.2 million for the quarter, compared to a loss of $27.1 million in the same period last year.
Analyst Perspective
William Blair analyst Margaret Kaczor Andrew noted that while the filing delay is disappointing, it allows iRhythm to focus on integrating certified cardiographic technicians into its regulatory processes, potentially strengthening future submissions.
