The Food and Drug Administration (FDA) recently approved prior design changes to iRhythm Technologies’ Zio AT, a wearable cardiac monitoring system. This approval was part of the first of two 510(k) submissions linked to the company’s efforts to address concerns raised by the FDA. In 2022, the FDA issued a warning letter to iRhythm for not seeking clearance before making modifications to the Zio AT system and for marketing it to a new, high-risk patient group without approval. These activities were discovered during an FDA inspection.
Despite the issues, Zio AT products are still available on the U.S. market. Quentin Blackford, CEO of iRhythm, announced on Monday that the company had submitted two 510(k) filings at the beginning of the year and expects to receive feedback on the second submission soon.
The Zio AT device is designed for non-critical care patients to wear while engaging in daily activities. It provides continuous monitoring of heart rhythms, although it does not offer real-time monitoring. The healthcare team receives the data from Zio AT to assist in diagnosing any arrhythmias, which are irregular heart rhythms. The recent corrections and enhancements to the Zio AT device are part of iRhythm’s strategic move to align with FDA regulations and demonstrate the company’s dedication to quality, compliance, and performance.
In May 2023, the FDA expressed concerns about iRhythm promoting the Zio AT as a mobile cardiac telemetry monitor for high-risk patients requiring near real-time monitoring, which was a shift from its original market. This shift necessitated additional 510(k) submissions to ensure compliance.
The modifications to the Zio AT that received FDA clearance include minor enhancements such as a new cellular chip designed to improve battery life. These modifications were previously reported through a letter to file—a common practice for documenting changes that do not affect the safety or efficacy of a device and do not require a fresh 510(k) submission.
Wall Street analysts responded positively to the news of the FDA clearance, expressing relief as it alleviates some regulatory concerns surrounding iRhythm. Analysts like BTIG’s Marie Thibault noted that the announcement mitigates some of the regulatory uncertainties affecting the company. Similarly, Joanne Wuensch from Citi Research highlighted that the device changes were minor modifications, emphasizing that the newly approved changes would enhance the product’s functionality and compliance.
Overall, the FDA’s recent clearance represents a critical step for iRhythm Technologies in their ongoing efforts to ensure their products meet regulatory standards and continue to serve the needs of patients with heart monitoring requirements. The clearance not only supports the company’s claims about Zio AT’s enhancements but also reaffirms iRhythm’s commitment to adhering to regulatory expectations, bolstering confidence among investors and customers alike.
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