Irhythm Technologies Inc Stock Price, News & Analysis

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.

iRhythm Technologies (NASDAQ:IRTC) has entered an exclusive license agreement with BioIntelliSense for multiparameter sensor technology in ambulatory cardiac monitoring (ACM). The deal grants iRhythm access to BioIntelliSense's patented pulse oximetry, accelerometry, and trending non-invasive blood pressure technologies for use in ACM products and services.

This collaboration aims to expand iRhythm's product capabilities, potentially entering adjacent indications like obstructive sleep apnea. The agreement includes an upfront payment to BioIntelliSense, with additional considerations based on future milestones and royalties on annual net sales in the home sleep testing field.

iRhythm reaffirms its 2024 financial guidance for revenue, gross margin, and adjusted EBITDA, excluding this transaction. The company expects no material incremental development expenses in 2024 beyond the acquired in-process research and development (IPR&D) expense.

iRhythm Technologies (NASDAQ:IRTC) presented results from the GUARD-AF trial at the European Society of Cardiology Congress 2024. The trial, using iRhythm's Zio® XT patch for long-term continuous monitoring (LTCM), aimed to evaluate screening for undiagnosed atrial fibrillation (AF) in elderly individuals.

Key findings include:

• Screening with Zio® XT LTCM led to increased AF diagnosis (5.0% vs 3.3%) over 15 months
• No significant difference in stroke hospitalization rates
• Increased oral anticoagulation initiation in the screened group (4.2% vs 2.8%)
• 88% of detected AF cases were low-burden paroxysmal AF

The study demonstrates the feasibility of primary care-initiated, home-based monitoring for AF detection in older populations.

iRhythm Technologies (NASDAQ:IRTC) has launched its Zio® cardiac arrhythmia monitoring service in Austria, the Netherlands, Switzerland, and Spain. The service includes the Zio monitor, a patch ECG device worn for up to 14 days, and the ZEUS System, an advanced AI algorithm for analysis.

Key features of the Zio LTCM service include:

• Up to 14 days of continuous ECG monitoring
• 99% patient compliance and analyzable time
• Highest diagnostic yield for specified arrhythmias
• Lowest likelihood of retesting and acute care utilization

The Zio monitor is 23% thinner, 62% lighter, and 72% smaller than previous versions, weighing only 10 grams. It has been clinically proven in over 100 scientific research papers and is backed by CE marking and FDA clearance.

iRhythm Technologies (NASDAQ:IRTC), a leading digital health care company, has announced its participation in three major investor conferences in September 2024. The company will present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 3:20 pm ET, the Wells Fargo 2024 Healthcare Conference on September 5 at 8:45 am ET, and the Baird 2024 Global Healthcare Conference on September 10 at 2:00 pm ET.

Interested parties can access live and archived webcasts of these presentations through the "Events & Presentations" section of iRhythm's investor website at investors.irhythmtech.com. This series of conferences provides an opportunity for iRhythm to showcase its trusted solutions for disease detection, prediction, and prevention to the investment community.