iRhythm Technologies (IRTC) Truist Securities MedTech Conference 2026 summary

Cybersecurity incident and operational impact

• Detected unauthorized access to data assets, including patient and proprietary data; incident is under active investigation and containment with external experts.

• No impact to products, operations, or patient safety; no expected material financial impact based on current assessment.

• Ongoing transparent communication with customers and investors; updates to be provided as the situation evolves, including by the Q2 earnings call.

• No effect on regulatory timelines or clinical/medical systems, including Zio MCT submission.

Zio MCT regulatory progress and product development

• FDA submission for Zio MCT prompted a shift from an existing gateway to a mobile phone gateway to address cybersecurity feedback.

• Design, testing, and data collection for the new gateway underway; full data package to be submitted to FDA by year-end, maintaining first half 2027 launch guidance.

• FDA prefers a complete submission over rolling data; this approach was anticipated in original guidance.

• Recent third-generation algorithm approval by FDA signals positive regulatory engagement.

AI algorithm advancements and efficiency gains

• Third-generation algorithm reduces cardiac technician review time by 50%, enabling significant operational efficiencies.

• Projected over $100 million in cost savings over five years due to AI-driven workflow improvements.

• Algorithm benefits apply across all product lines; launch aligned with Zio MCT introduction to prioritize resources.

• Ongoing development of future algorithm generations expected to further enhance efficiency and insights.