iRhythm Raises 2026 Revenue Outlook
The medical device maker lifted its full-year revenue range while delaying its Zio MCT regulatory filing to 2027.
Updated on Nov. 7, 2026 in Healthcare
iRhythm Holdings raised its 2026 revenue outlook to $890 million to $895 million after third-quarter revenue reached $221.6 million, up nearly 15% from a year earlier. The company said it no longer plans to submit its Zio MCT device to the FDA in 2026 and now expects to file in 2027.
Why it matters
The revised outlook reflects strength in the Zio Monitor business, which outperformed expectations, while the delayed FDA submission pushes back a new product's path to market. For U.S. patients and providers relying on ambulatory cardiac monitoring, the timeline shift affects when the next-generation device could become available.
iRhythm reported third-quarter revenue of $221.6 million, up nearly 15% from a year earlier, with Zio AT revenue roughly flat. The company expects Zio AT revenue to fall about 10% in the fourth quarter, and customer onboarding delays are expected to persist in the near term.
The players
iRhythm Holdings
iRhythm Holdings is a medical technology company that makes wearable cardiac monitoring devices, including the Zio line of ambulatory ECG monitors.
The details
Zio Monitor performed better than expected in the third quarter, while Zio AT revenue was roughly flat year over year. iRhythm also reiterated a target for an adjusted EBITDA margin of at least 15% in 2027.
Timeline
Q3 2026: Third-quarter revenue reported at $221.6 million.
Q4 2026: Zio AT revenue expected to decline about 10%.
2026: Revenue outlook raised; Zio MCT FDA filing no longer planned this year.
2027: Zio MCT FDA submission expected.
Healthcare Industry Trajectory
The delayed Zio MCT submission pushes the company's next-generation cardiac monitoring product into 2027, while the established Zio Monitor line continues to drive growth. The timing places iRhythm's expansion pace against its own product pipeline rather than a single competitor's launch.
Patients and clinicians using ambulatory heart monitors may see continued availability of the existing Zio line while the next-generation Zio MCT remains under review until 2027. The company's delayed filing means the newer device is not expected to reach the market in the near term.
The takeaway
Companies in regulated medical device markets often face timelines that shift between filing and approval, so readers tracking a specific product should watch for updated FDA submission dates. Revenue guidance and product timing can move independently, as this quarter shows.
What happens next
iRhythm expects to submit its Zio MCT device to the FDA in 2027 and reiterated its target of an adjusted EBITDA margin of at least 15% for that year.
Further reading
Explore more Healthcare coverage for context on device makers and regulatory timelines.
