iRhythm Technologies is a digital healthcare company that develops wearable cardiac monitoring devices and AI-driven diagnostic solutions for detecting heart rhythm disorders such as arrhythmias.
You mentioned last year that expanding into primary care settings was a key priority. How far have you advanced in that undertaking?
It’s been a huge focus for us, and it’s paying off. There are around six million cardiac monitoring tests conducted in the U.S. each year, but we believe about 27 million people in the U.S. alone each year are at risk for undiagnosed arrhythmias without knowing it, and can benefit from proactive cardiac monitoring. Not all of them will see a cardiologist, so we need to move up the care pathway—into primary care—where patients are already being seen. That’s why this expansion is so crucial to our goal of reaching and helping as many people as possible. Today, over a third of our prescriptions come from primary care physicians, which is remarkable progress.
Primary care is now our fastest-growing segment and channel. We’ve also seen strong growth in innovative health channel partnerships, often involving large national primary care networks. These partners understand the value of earlier intervention and preventative care.
Traditionally, U.S. healthcare has been reactive—waiting for symptoms or emergency episodes, which are costly and sometimes catastrophic.
Our data shows we can identify these patients earlier in their care journey, particularly through primary care. Once identified, appropriate patients can be proactively monitored using our clinically proven Zio ECG monitors and service to help clinicians diagnose them before they ever get to an emergency room – to improve outcomes and reduce health care costs.
Could you tell us more about recent studies on early arrhythmia detection that iRhythm was involved in?
These relate to our work with EVERSANA, independent large-scale real-world studies across patient populations with an elevated risk for arrhythmia, those with comorbid conditions including Type 2 diabetes (T2D), chronic kidney disease (CKD), and chronic obstructive pulmonary disease (COPD), that add to the growing body of evidence further supporting the case for proactive cardiac monitoring.
This is important evidence. Cardiac arrhythmias are a serious public health concern, affecting roughly 1 in 20 adults in the general U.S. population. But in people with T2D or CKD, already at elevated cardiovascular risk—these new data reveal that arrhythmias occur more frequently, and often much earlier, than previously recognized.
The studies also show that patients with T2D and COPD who received ambulatory ECG monitoring had substantially lower healthcare utilization: 70% fewer hospitalizations, 44% fewer readmissions, and nearly 50% fewer ER visits compared to unmonitored patients.
What’s exciting is that we’re leading the charge in proactive monitoring at iRhythm, and
we’re using AI to identify patients likely to have arrhythmias before they’re diagnosed. Our AI already powers our 14-day cardiac monitoring, analyzing millions of heartbeats for irregularities. Now, as previously announced, in partnership with Lucem Health, we’re integrating predictive AI capabilities, building on our existing proactive monitoring programs. The exclusive AI-powered solution analyzes subtle patterns in clinical and electronic health record (EHR) data to help identify elevated arrhythmia risk in individuals who may otherwise not be flagged as candidates for cardiac monitoring. By combining AI with large datasets, we can proactively find patients at risk and confirm their diagnosis with our Zio ECG monitoring device and service.
Early pilot tests suggests promising improvement in targeting patient populations with elevated arrhythmia. In the first, a 1000-patient pilot across people with T2D, we found over 90% had an arrhythmia. In a second pilot, also in T2D patient population, results were similarly strong.
This is exciting – as we look to reach the 27 million people at risk for undiagnosed arrhythmia. .
Do you envision broader proactive monitoring initiatives among at-risk populations?
Absolutely. Our initial efforts are focused on comorbid disease patient populations where arrhythmias are highly prevalent, such as T2D, COPD, CKD, and sleep disorders.
Have you estimated how much health systems could save through earlier arrhythmia detection?
Yes, early findings are compelling. EVERSANA’s independent study showed that for every 1,000 patients kept out of the emergency room through early arrhythmia diagnosis, the healthcare system saves about $10 million. That’s a huge cost reduction. Our focus is to find patients likely to have an arrhythmia earlier, get a Zio ECG monitor on them, get them diagnosed, and prevent the most expensive outcomes—emergency visits and hospital admissions.
We’re already demonstrating that we can bend that cost curve meaningfully. It’s not just about health outcomes—it’s also about fiscal discipline and supporting national healthcare objectives like preventative care and efficiency.
Are you engaging with policymakers around these healthcare cost benefits?
Yes. Our value proposition aligns closely with national healthcare priorities: earlier and proactive care, preventative medicine, and precision-based approaches. We’re in ongoing discussions with CMS, commercial payers, reinsurers, and self-insured employers. They all have a vested interest in improving outcomes while reducing system-wide costs. Our platform effectively brings that full-circle solution to the table.
But we go beyond a diagnosis—once we help proactively identify patient populations at risk for undiagnosed arrhythmia, we help build a care pathway. Often, that includes connecting them with third-party virtual cardiology services to manage their patients’ condition and ensure cost reduction.
You had mentioned previously that one of your priorities was addressing FDA concerns regarding the classification of your devices. How is that discussion progressing?
That’s been one of our biggest success stories. Over the past four years, we’ve transformed our relationship with the FDA into a collaborative and transparent partnership. We now have regular dialogue about our innovation roadmap, new product features, and data requirements for approval.
We’ve resolved all issues identified in our previous warning letter and subsequent observations, and we’ve formally notified the FDA of our remediation. We’re awaiting their review. Meanwhile, we’ve proactively engaged a third-party auditor to assess our work independently and share those findings with the agency. It’s a proud milestone for us.
This year, you’ve also expanded into Japan…
Yes, Japan has been our major international milestone for 2025. We’re now active in seven countries, mostly across the EU and the UK, but Japan is particularly exciting—it’s the world’s second-largest ambulatory cardiac monitoring market, with over 1.5 million tests annually. The government granted a high medical-need designation specifically for our Zio product, which gives us strong visibility and credibility.
We’re gaining traction among hospital systems and the Japanese Heart Rhythm Society. The next step is improving reimbursement rates. The market has deep loyalty to domestic Holter monitor manufacturers, so we’re running head-to-head clinical trials comparing Zio directly to those devices in Japanese patients. We expect results and regulatory progress in the first half of next year.
AI is clearly central to your strategy. Are there any new collaborations or innovations underway?
Definitely. AI is central to our strategy, and we’re advancing it in a few important ways. First, within cardiac monitoring, we recently submitted an enhanced, next-generation version of our arrhythmia-detection algorithm to the FDA. It further improves accuracy and alignment with expert cardiologists, and there’s still significant room to keep advancing those capabilities. And of course – the predictive AI in collaboration with Lucem Health to further advance our proactive monitoring approaches.
But we’re also expanding beyond cardiac conditions with AI capabilities to identify other health issues, starting with sleep disorders such as obstructive sleep apnea, using the same chest patch platform.
This underscores the importance of getting into primary care -- if you can make it as easy to look for cardiac arrhythmias in other disease states in this care setting, you're going to have a right to win to look for other diseases.
From there, our broader vision is to to expand into full vital-sign monitoring. Imagine being able to track a patient’s vitals after hospital discharge for 30–60 days, detecting deterioration early and intervening before readmission. That could save the healthcare system trillions annually. With our platform, patch monitoring technology, and large independent diagnostic testing facility (IDTF) capabilities and trained technicians, we believe we’re uniquely positioned to make that proactive care model a reality.
Looking ahead, where would you like to see the company one year from now?
A year from now, I expect us to have a much larger presence in primary care and to make significant strides in sleep and other disease areas. You’ll see more data and evidence showing that we can proactively find patients who have arrhythmias before they lead to acute episodes and ever show up in the ER, improving outcomes and reducing costs.
We’ll continue positioning iRhythm Technologies as a transformative force in healthcare—embodying proactive, preventative, and precision medicine. Our platform is built to address where healthcare is heading, and we’re only at the beginning of realizing that potential.
