FDA Clearance Boosts iRhythm Zio Device Innovation and Fuels Growth Potential

iRhythm Technologies, Inc. (NASDAQ:IRTC) is one of the 10 Stocks with Huge Catalysts on the Horizon.

The FDA clearance for the Zio AT device upgrades signals the potential for further innovation and stock growth.

FDA Clearance Boosts iRhythm Zio Device Innovation and Fuels Growth Potential

A patient being monitored with a portable ECG device, showing the effectiveness of the company’s products.

Based in California, iRhythm Technologies, Inc. (NASDAQ:IRTC) is a digital healthcare company focused on transforming cardiac arrhythmia detection through wearable biosensors and cloud-based data analytics. Zio by iRhythm platform, the company’s flagship product, makes use of a wearable biosensor patch and cloud-based analytics for monitoring heart rhythms for extended periods, aiding in the diagnosis of cardiac arrhythmias.

iRhythm Technologies, Inc. (NASDAQ:IRTC) recently got the FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device – a prescription-only mobile cardiac telemetry (MCT) system used for long-term ECG monitoring of both symptomatic and asymptomatic heart events. The clearance, effective from 2025, allows the device to remain commercially available in the U.S. Following the clearance, the company also launched Zio ECG Recording and Analysis System in Japan in May 2025, with nationwide availability anticipated by July 2025.

Following these developments, Robert W. Baird maintained a Buy rating on the stock with a price target of $160. With a 1.17% uptick in its weekly performance, the stock had a closing price of $137.11 as of July 28, 2025.

Insider Monkey database reported 31 hedge funds holding stakes in iRhythm Technologies, Inc. (NASDAQ:IRTC), reflecting a modest level of institutional confidence.

While we acknowledge the risk and potential of IRTC as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than IRTC and that has 10,000% upside potential, check out our report about this cheapest AI stock.

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