FDA Clearance Boosts iRhythm Zio Device Innovation and Fuels Growth Potential
The FDA clearance for the Zio AT device upgrades signals the potential for further innovation and stock growth.
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 potential of IRTC as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.
READ NEXT: 11 Best Long Term Low Risk Stocks to Invest in and 13 Best Low Risk High Growth Stocks to Buy
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