With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says

On Monday, the FDA approved iRhythm Technologies, Inc.’s IRTC 510(k) submission related to prior design changes to the Zio AT device via letter to file.

Zio AT remains commercially available to ship to customers in the United States.

“We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future,” said Quentin Blackford, iRhythm President and CEO.

The Zio AT device is a prescription-only outpatient cardiac telemetry device, commonly called a mobile cardiac telemetry device, used to provide mobile cardiac telemetry (MCT) services.

The Zio AT system consists of the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days, and the wireless gateway that provides connectivity between the Zio AT patch and the Zio ECG Utilization Software (ZEUS) to transmit data.

William Blair reports that iRhythm’s management anticipates a second approval in the “near future.” Given the submission timelines, which were about a week apart in early January, the company could still meet its internal goal of securing approval by October.

With iRhythm expected to announce its third-quarter results next week, the analyst anticipates an update on the second 510(k) clearance by then.

William Blair views the update as a positive sign that iRhythm is progressing in resolving its FDA concerns and aligning with the agency on its longer-term quality strategy as it heads into 2025.

Additionally, the analyst believes the introduction of mobile cardiac telemetry (MCT) technology could help iRhythm narrow the competitive gap. By extending its current 14-day wear time closer to the 30-day benchmark of rival devices and enabling the system to function as an event monitor if prior authorization denies MCT use, iRhythm is expected to enhance its market position.

The analyst maintains the Outperform rating on iRhythm Technologies stock.

Price Action: IRTC stock is up 20.30% at $74.70 at last check Tuesday.

Read Next:

• Marlboro Maker Philip Morris Highlights Strong Q3 Performance On Higher Prices, Issues Upbeat Annual Forecast.