iRhythm(IRTC)

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iRhythm(IRTC) - 2024 Q3 - Quarterly Results
2024-10-30 20:10
Exhibit 99.1 iRhythm Technologies Announces Third Quarter 2024 Financial Results SAN FRANCISCO, October 30, 2024 - iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three months ended September 30, 2024. Third Quarter 2024 Financial Highlights • Revenue of $147.5 million, an 18% increase compared to third quarter 2023 • Gross margin of 68.8%, a 260-basis po ...
Newly Published Research Shows 14-Day Monitoring Detected Almost Three Times More Nonsustained Ventricular Tachycardia Than Standard 48-Hour Monitoring in Patients with Hypertrophic Cardiomyopathy
GlobeNewswire News Room· 2024-10-28 12:02
Hypertrophic cardiomyopathy (HCM) is a genetic heart condition affecting about 1 in 500 people and is one of the leading causes of sudden cardiac death (SCD) in people under 35, including among athletes.1 NSVT (nonsustained ventricular tachycardia), a known marker for increased risk of SCD in HCM, was detected in nearly 50% of HCM patients in the study undergoing long-term continuous ambulatory ECG monitoring of up to 14 days with a Zio® XT LTCM ECG patch device; 63% of NSVT episodes detected only after 48 ...
iRhythm Technologies (IRTC) Soars 21.7%: Is Further Upside Left in the Stock?
ZACKS· 2024-10-23 12:50
iRhythm Technologies (IRTC) shares soared 21.7% in the last trading session to close at $75.59. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 11.4% loss over the past four weeks.iRhythm Technologies scored a strong price increase driven by the optimism surrounding the recent FDA 510(k) clearance for design changes and enhancements previously made to its Zio AT device. It supports the company’s remediation efforts with the FDA a ...
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
Benzinga· 2024-10-22 17:18
On Monday, the FDA approved iRhythm Technologies, Inc.’s IRTC 510(k) submission related to prior design changes to the Zio AT device via letter to file.Zio AT remains commercially available to ship to customers in the United States.“We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future,” said Quentin Blackford, iRhythm President ...
Kaskela Law LLC Announces Shareholder Investigation of iRhythm Technologies, Inc. (NASDAQ: IRTC) and Encourages Long-Term IRTC Shareholders to Contact the Firm
GlobeNewswire News Room· 2024-09-20 12:00
PHILADELPHIA, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it is investigating iRhythm Technologies, Inc. (NASDAQ: IRTC) ("iRhythm") on behalf of the company's long-term shareholders. https://kaskelalaw.com/case/irhythm-technologies/ Recently a securities fraud complaint was filed against iRhythm on behalf of investors who purchased shares of the company's stock between November 5, 2021 and May 30, 2023 (the "Class Period"). According to the complaint, during the Class Period iRhythm an ...
iRhythm's Zio ECG System Gets Approval in Japan, Stock Falls
ZACKS· 2024-09-13 15:55
iRhythm Technologies, Inc. (IRTC) has received regulatory approval from Japan's Pharmaceutical and Medical Device Agency for its Zio long-term continuous ECG monitoring (LTCM) system. The Zio system, which provides 14 days of continuous heart monitoring, combines a wearable patch device with AI-powered analysis through Zio ECG Utilization Software for high diagnostic accuracy to help doctors make the right diagnosis the first time. With this approval, iRhythm aims to secure reimbursement from Japan's Minist ...
iRhythm Technologies Announces Japanese Regulatory Approval of the Zio® ECG Monitoring System, the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence
GlobeNewswire News Room· 2024-09-11 12:05
Zio ECG monitoring system is the only fourteen-day cardiac monitoring service in its category to receive Japanese regulatory approval as an improved device without a clinical trial Zio ECG monitoring system previously received Japanese high medical needs designation, a unique distinction reflecting positive recommendation by the Japanese Heart Rhythm Society (JHRS) iRhythm will continue working towards reimbursement to enable market access in Japan, the world's second largest medical device market Japan is ...
iRhythm Stock Gains Following Favorable Zio Monitor Study Data
ZACKS· 2024-09-10 17:14
iRhythm Technologies (IRTC) recently announced initial research findings on the post-market, real-world performance of the Zio monitor, IRTC's next-generation Zio long-term continuous monitoring (LTCM) patch ECG device. The findings are presented at the Heart Rhythm Society's HRX 2024 meeting. The impact of design enhancements on device performance, with even better wear time and analyzable time with the new device, was observed in the findings. Taken together, these advancements are likely to contribute to ...
iRhythm Stock May Gain on Its Latest Deal With BioIntelliSense
ZACKS· 2024-09-09 16:01
Core Viewpoint - iRhythm Technologies (IRTC) has signed an exclusive license agreement with BioIntelliSense to develop and commercialize patented technology in ambulatory cardiac monitoring (ACM) [1][2]. Company Summary - The agreement allows iRhythm to utilize BioIntelliSense's multiparameter sensing technologies, enhancing its platform capabilities and potentially enabling entry into adjacent indications like obstructive sleep apnea [2]. - The licensing agreement is expected to boost iRhythm's business and revenue growth in the ACM segment, attracting investor interest and potentially increasing share price [3]. - iRhythm will pay an upfront fee and additional payments based on regulatory milestones and technology validation, with royalties from net sales related to home sleep testing [7]. Financial Outlook - iRhythm reaffirmed its 2024 financial guidance, projecting revenue growth of approximately 18% to 20%, amounting to $580 million to $590 million [9]. - The gross margin for 2024 is expected to be between 68.5% and 69%, with an adjusted EBITDA margin of approximately 3.5% to 4% of revenues [9][10]. - The company anticipates no significant incremental development expenses in 2024, aside from the acquired in-process research and development (IPR&D) expense related to the agreement [10]. Industry Insights - The ambulatory cardiac monitoring market was valued at $5.8 billion in 2022 and is projected to grow at a CAGR of 10.4% from 2023 to 2030, indicating strong market potential for iRhythm's new agreement [11]. - iRhythm's stock has performed well, gaining 29.8% over the past six months, outperforming the industry growth of 8.9% and the S&P 500's gain of 17.3% during the same period [12].
iRhythm Unveils Data Demonstrating Superior Real-World Performance of Next-Generation Zio® Monitor at HRX 2024 Meeting
GlobeNewswire News Room· 2024-09-09 12:05
iRhythm's next-generation Zio® monitor demonstrated longer wear duration and analyzable time compared to the prior generation Zio® XT device. Longer wear duration and analyzable time may further improve diagnostic yield, building upon Zio XT service's superior yield among ambulatory cardiac monitoring services as demonstrated by the prior CAMELOT study findings.1 The Zio monitor ECG device has been worn by over 1 million patients since launching in late 2023.2 SAN FRANCISCO, Sept. 09, 2024 (GLOBE NEWSWIRE) ...