iRhythm Holdings, Inc.
Case Overview
| Status: | Status:Investigating |
| Company Name: | Company Name:iRhythm Holdings, Inc. |
| Ticker: | Ticker:IRTC |
| Related Attorneys: | Lead Attorneys:Thomas W. Elrod |
| Related Practices: | Related Practices:Securities |
On November 5, 2026, iRhythm reported its third quarter 2026 financial results, revealing revenue of $221.6 million, below consensus estimates, and flat year-over-year revenue for Zio AT. Additionally, the Company announced that it no longer plans to submit Zio MCT, the Company’s next-generation mobile cardiac telemetry (“MCT”) platform, to the FDA this year. iRhythm stated it now expects to submit its Zio MCT filing to the FDA in 2027, attributing the new timeline to the integration of VitalConnect, which iRhtyhm closed a deal to acquire on October 5, 2026. iRhythm CEO Quentin Blackford stated, “With VitalConnect, we immediately have an additional FDA-cleared MCT offering, and integrating this technology will be our near term priority. As a result, we no longer plan to submit Zio MCT to the FDA later this year.”
The announcement was a departure from the previous timeline set and reaffirmed by the Company. On February 19, 2026, iRhythm management stated that its new Zio MCT product was under review with the FDA and that they “expect to release the product in the first half of 2027.” The Company reaffirmed this timeline in its April 30, 2026 earnings call, as well as on August 6, 2026, when the Company announced the acquisition of VitalConnect. When asked on August 6 if the acquisition meant the Company was deprioritizing Zio MCT, Blackford stated, “[W]e are continuing our effort on MCT. We’re not backing away from MCT.” On the November 5, 2026 news, the price of iRhythm shares declined by $39.97 per share, or approximately 30.7%, from $130.19 per share on November 5, 2026 to close at $90.22 on November 6, 2026.
The announcement was a departure from the previous timeline set and reaffirmed by the Company. On February 19, 2026, iRhythm management stated that its new Zio MCT product was under review with the FDA and that they “expect to release the product in the first half of 2027.” The Company reaffirmed this timeline in its April 30, 2026 earnings call, as well as on August 6, 2026, when the Company announced the acquisition of VitalConnect. When asked on August 6 if the acquisition meant the Company was deprioritizing Zio MCT, Blackford stated, “[W]e are continuing our effort on MCT. We’re not backing away from MCT.” On the November 5, 2026 news, the price of iRhythm shares declined by $39.97 per share, or approximately 30.7%, from $130.19 per share on November 5, 2026 to close at $90.22 on November 6, 2026.