iRhythm Technologies Receives FDA Clearance for Zio AT Device, Stock Soars 20%
In a significant development for iRhythm Technologies, Inc. (IRTC), the FDA has approved the company’s 510(k) submission related to prior design changes for its Zio AT device. The Zio AT device, a prescription-only outpatient cardiac telemetry device commonly known as a mobile cardiac telemetry (MCT) device, is now cleared for commercial availability in the United States.
This clearance represents a positive step for iRhythm, which has been working to resolve FDA concerns and align with the agency’s long-term quality strategy. The company submitted two 510(k)s earlier this year and is anticipating approval for the second one in the near future. Quentin Blackford, iRhythm President and CEO, expressed his satisfaction with the first clearance, stating, “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.”
Analysts view this approval as a positive sign for iRhythm’s future. William Blair, a financial firm, expects the company to announce the second 510(k) clearance during its third-quarter results announcement next week. This clearance could further enhance iRhythm’s market position by enabling the Zio AT system to function as an event monitor if prior authorization denies MCT use. By extending the wear time closer to the 30-day benchmark of rival devices, iRhythm is expected to narrow the competitive gap in the MCT market.
The news of the FDA clearance has driven a significant surge in IRTC stock price. At last check on Tuesday, the stock was up 20.30% at $74.70. William Blair maintains an Outperform rating on iRhythm Technologies stock, reflecting their positive outlook on the company’s future prospects.
The Zio AT system includes the Zio AT patch, which continuously records ECG data for up to 14 days, and a wireless gateway that provides connectivity between the patch and the Zio ECG Utilization Software (ZEUS) for data transmission. The Zio AT device is a valuable tool for healthcare professionals to monitor and diagnose heart conditions. With the recent FDA clearance and the anticipation of the second clearance, iRhythm is well-positioned to capitalize on the growing market for MCT devices.
