Welcome to our dedicated page for iRhythm Technologies news (Ticker: IRTC), a resource for investors and traders seeking the latest updates and insights on iRhythm Technologies stock.
iRhythm Technologies, Inc. (NASDAQ: IRTC) is a commercial-stage digital healthcare company redefining the diagnosis of cardiac arrhythmias through its innovative technologies. By combining wearable biosensing technology with cloud-based data analytics and advanced machine learning capabilities, iRhythm aims to be the leading provider of first-line ambulatory electrocardiogram (ECG) monitoring, particularly for patients at risk of arrhythmias.
The company's flagship product, the Zio service, represents a comprehensive solution that includes an easy-to-wear biosensor capable of monitoring a patient's heart rhythm continuously for up to 14 days. This device, paired with the company's proprietary algorithms, transforms millions of heartbeats into clinically actionable data, significantly enhancing the diagnostic yield compared to traditional Holter monitors and other event monitoring systems. This approach not only expedites diagnosis but also reduces the need for repeat testing, thereby allowing timely medical intervention and potentially preventing severe outcomes like stroke.
Recent accomplishments highlight iRhythm's commitment to advancing cardiac care. The Zio monitor system has received the CE mark, underscoring its recognition as a leading innovation in ambulatory cardiac monitoring. The Zio monitor is designed to be thinner, lighter, and more discreet than its predecessor, the Zio XT, while improving patient compliance and monitoring accuracy. Furthermore, the company has integrated the ZEUS (Zio ECG Utilization Software) System, an advanced AI algorithm, to enhance data analysis and capture.
iRhythm's clinical research, such as the Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (CAMELOT) study, has demonstrated the superior diagnostic accuracy and lower retest rates of the Zio service. These findings, published in the American Heart Journal, indicate significant advantages in clinical utility and cost-effectiveness over other monitoring systems.
On the financial front, iRhythm has shown robust performance, with significant increases in gross profit driven by higher demand for Zio services. The company's strategic initiatives include expanding its market presence in Europe, strengthening customer engagement through digital tools, and launching new products. The recent closure of a substantial non-dilutive senior secured term loan facility ensures continued financial flexibility and supports iRhythm's growth ambitions.
With nearly 8 million reports posted since its inception, iRhythm remains focused on delivering better data, better insights, and better health outcomes. The company's relentless focus on patient care and strategic partnerships positions it well for sustained growth and innovation in the digital healthcare landscape.
iRhythm Technologies (NASDAQ: IRTC) announced its participation in the upcoming Citi 2024 Global Healthcare Conference. The digital health care company's management will engage in a fireside chat on Wednesday, December 4, 2024, at 10:15 am Eastern Time.
The presentation will be accessible through a live and archived webcast on the 'Events & Presentations' section of iRhythm's investor website at investors.irhythmtech.com. The company specializes in creating trusted solutions for disease detection, prediction, and prevention.
iRhythm Technologies (NASDAQ:IRTC) presented five new studies at the American Heart Association's 2024 Scientific Sessions, focusing on three key areas of long-term continuous monitoring (LTCM): digital patient engagement, arrhythmia patterns during sleep/activity, and healthcare economic impact. Key findings showed that digital tools improved device return compliance to 94.8% when both app and text messaging were used, compared to 74.6% without digital intervention. The new Zio monitor demonstrated 14% better wear comfort than its predecessor. A significant cost analysis revealed higher healthcare costs for arrhythmia patients with diabetes and COPD, suggesting potential savings through early detection.
iRhythm Technologies (NASDAQ:IRTC) announced its participation in the Wolfe Research 2024 Healthcare Conference. The digital health care company's management will engage in a fireside chat on Tuesday, November 19, at 9:50 am Eastern Time. The presentation will be accessible through a live and archived webcast on the company's investor website under the 'Events & Presentations' section at investors.irhythmtech.com.
iRhythm Technologies (NASDAQ:IRTC) has received FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device, which provides ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients. The enhancements, addressing concerns noted in a 2023 FDA warning letter, will be available in 2025. The Zio AT device, used in conjunction with the Zio ECG Utilization Software (ZEUS), remains commercially available in the United States while the approved modifications are implemented.
iRhythm Technologies (IRTC) reported Q3 2024 financial results with revenue of $147.5 million, up 18% year-over-year. Gross margin improved to 68.8%, a 260-basis point increase from Q3 2023. The company recorded a net loss of $46.2 million, or $1.48 per share. Notable achievements include record demand from existing accounts, new account openings in the US, and record UK registrations. The company expanded globally into Austria, Netherlands, Switzerland, and Spain, and received Japanese PMDA approval. Full-year 2024 guidance projects revenue growth of 18-19% to $582.5-587.5 million, with gross margin expected between 68.5-69.0%.
iRhythm Technologies (NASDAQ:IRTC) announced research results showing that 14-day monitoring using Zio® XT patch detected nearly three times more nonsustained ventricular tachycardia (NSVT) compared to standard 48-hour monitoring in patients with hypertrophic cardiomyopathy (HCM). The study found that 48% of HCM patients experienced NSVT episodes during the 14-day period, with 63% of these episodes detected only after 48 hours. High-risk NSVT was detected in 24% of patients, representing a 3-fold greater diagnostic yield compared to 48-hour monitoring. The findings suggest that traditional short-term monitoring may miss significant cardiac events that could indicate increased risk of sudden cardiac death.
iRhythm Technologies (NASDAQ:IRTC) has received FDA 510(k) clearance for design updates previously made to its Zio AT device. The Zio AT, along with the Zio ECG Utilization Software (ZEUS), enables ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients. This clearance is related to modifications and enhancements made via letter to file and demonstrates iRhythm's commitment to quality, compliance, and performance.
CEO Quentin Blackford stated that this is the first of two 510(k) clearances submitted at the beginning of the year, with the company expecting to hear about the second one soon. Both submissions are part of ongoing remediation efforts with the FDA. iRhythm remains committed to patient safety, physician trust in Zio AT's clinical performance, service quality, and regulatory compliance.
iRhythm Technologies (NASDAQ:IRTC), a leading digital health care company, has announced it will release its third quarter 2024 financial results after the close of trading on Wednesday, October 30, 2024. The company's management team will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results. Interested parties can access a live and archived webcast of the presentation on the 'Events & Presentations' section of iRhythm's investor website at investors.irhythmtech.com.
iRhythm Technologies (NASDAQ:IRTC) has received Japanese regulatory approval for its Zio® ECG Monitoring System, marking a significant milestone in the company's global expansion. The Zio system, which offers 14-day continuous ECG monitoring, is the first in its category to receive approval in Japan without a clinical trial. Key points include:
- Zio previously received a high medical needs designation in Japan
- Japan is the world's second-largest medical device market
- An estimated 1.6 million cardiac monitoring tests are prescribed annually in Japan
- iRhythm will now work towards securing reimbursement for market access
- The Zio system utilizes advanced AI algorithms for arrhythmia detection
This approval positions iRhythm to address the growing need for improved cardiac arrhythmia diagnostics in Japan's aging population.
iRhythm Technologies (NASDAQ:IRTC) presented data at HRX 2024 showcasing the superior performance of its next-generation Zio® monitor compared to the previous Zio® XT device. The study revealed that the new Zio monitor demonstrated fewer early wear terminations (1.1% vs 2.8%), longer wear duration (12.6 vs. 11.9 days), and longer analyzable time (12.2 vs 11.5 days). These improvements may lead to enhanced diagnostic yield, building upon Zio XT's already superior performance among ambulatory cardiac monitoring services. The new Zio monitor also showed higher detection rates for paroxysmal AF (8.7% vs 6.8%) and overall arrhythmia (80.9% vs 76.4%). Since its launch in late 2023, the Zio monitor has been worn by over 1 million patients, demonstrating its rapid adoption in the market.
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