Irhythm Technologies Inc - IRTC STOCK NEWS

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.