iRhythm Receives FDA Clearance for Zio AT Enhancements, Faces Delay in Zio MCT Submission

Key Insights

• iRhythm Technologies secured FDA 510(k) clearance for design modifications and labeling updates to its Zio AT mobile cardiac telemetry device, addressing concerns from a prior FDA warning letter.
• The enhancements to Zio AT, which include design features and labeling updates, are intended to improve the technology for patients, physicians, and healthcare systems.
• Despite the Zio AT clearance, iRhythm's plans to submit its Zio Mobile Cardiac Telemetry (MCT) system to the FDA have been delayed to the third quarter of 2025 due to remediation efforts related to Zio AT.

iRhythm Technologies has received FDA 510(k) clearance for design modifications and labeling updates to its Zio AT mobile cardiac telemetry device. This clearance addresses concerns raised in a 2023 FDA warning letter regarding labeling, quality systems, and medical device reporting. The company plans to roll out these enhancements in 2025.

Zio AT Enhancements and FDA Warning Letter

The FDA's warning letter cited instances where iRhythm failed to report patient deaths within the required 30-day window. The recent clearance pertains to design features and labeling updates specifically aimed at resolving these issues. According to iRhythm President and CEO Quentin Blackford, these enhancements are intended to advance the technology and benefit patients and healthcare providers who rely on Zio AT services.

Delay in Zio MCT Submission

Despite the positive news regarding Zio AT, iRhythm has announced a delay in the FDA submission for its Zio Mobile Cardiac Telemetry (MCT) system. Originally slated for the end of 2024, the submission is now expected in the third quarter of 2025. This delay is attributed to ongoing remediation efforts related to the Zio AT device.

BTIG analysts Marie Thibault and Sam Eiber estimate that this delay could represent a potential $10 million revenue opportunity lost in 2025. The analysts noted that the delay comes with higher spending, though likely to be offset by other cuts.

Third-Quarter Earnings Report

iRhythm's third-quarter earnings report revealed a net loss of $46.2 million, or $1.48 per share, on sales of $147.5 million for the three months ended September 30, 2024. This represents a 70.3% bottom-line slide despite an 18.4% increase in sales. Adjusted losses per share were $1.26, falling short of Wall Street projections of 57 cents per share. However, sales exceeded expectations of $146.7 million.

Despite the mixed results, iRhythm projects full-year revenue growth between $582.5 million and $587.5 million, representing an 18%-19% increase. Analysts at BTIG maintain a "Buy" rating for iRhythm, citing the company's healthy core business and achievable full-year sales outlook, but acknowledge potential investor frustration due to the regulatory timeline delay.