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iRhythm Technologies, Inc. (IRTC) Shares Surge 96% Despite FDA Warning and Legal Challenges

By Laiba Immad | September 30, 2025, 12:35 PM

We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now.  iRhythm Technologies, Inc. is one of them.

iRhythm Technologies, Inc. (NASDAQ:IRTC) is a digital healthcare leader specializing in device-based ambulatory cardiac monitoring, with its flagship Zio platform combining wearable biosensors, cloud analytics, and proprietary algorithms to deliver actionable cardiac data efficiently.

In September 2025, IRTC faced regulatory and legal challenges, including an FDA Warning Letter concerning its Zio AT System and a securities class action lawsuit linked to prior non-conformity findings. These developments have heightened perceived risks around compliance and corporate governance.

Despite these headwinds, the corporation demonstrated strong financial performance. Q2 2025 revenue reached $186.7 million, up 26.1% year-over-year, surpassing analyst expectations. Year-to-date, IRTC shares have gained nearly 96%, reflecting investor confidence in its growth trajectory.

iRhythm Technologies, Inc. (IRTC) Shares Surge 96% Despite FDA Warning and Legal Challenges

Looking ahead, iRhythm Technologies, Inc. (NASDAQ:IRTC) ’s expansion plans center on broadening Zio’s adoption beyond traditional cardiology into international markets and other healthcare segments. Ongoing clinical validation trials, like AMALFI for high-risk atrial fibrillation detection, support this growth. Innovation efforts include next-generation wearable patches, AI-enhanced analytics, and partnerships such as with Lucem Health to improve diagnostic accuracy, workflow efficiency, and margins.

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: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy NOW 

Disclosure: None.

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