IRhythm Technologies (IRTC) came out with a quarterly loss of $1.26 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.89 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -129.09%. A quarter ago, it was expected that this company would post a loss of $0.92 per share when it actually produced a loss of $0.61, delivering a surprise of 33.70%. Over the last four quarters, the company has ...

Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients FDA 510(k)-cleared enhancements will be available in 2025 SAN FRANCISCO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Admini ...

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 ...

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 ...

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 ...

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 ...

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 ...

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].

Core Insights - iRhythm Technologies, Inc. (IRTC) has launched its Zio monitor and long-term continuous ECG monitoring service in Austria, the Netherlands, Spain, and Switzerland, emphasizing its commitment to global patient-centered digital healthcare solutions [1][6] - The Zio monitor offers up to 14 days of uninterrupted ECG monitoring, significantly improving the detection and management of cardiac arrhythmias, particularly atrial fibrillation, which is on the rise in Europe [3][5] Product Significance - Cardiac arrhythmias can lead to severe health risks, including stroke and death, making early detection and treatment essential for improving patient outcomes [2] - The Zio system provides extended monitoring capabilities that surpass traditional methods, enhancing diagnostic accuracy and streamlining clinical workflows [3][4] Market Expansion - iRhythm Technologies plans to begin shipping the Zio monitor in the mentioned European countries starting in September, with widespread availability expected by 2025 [6] - The Zio monitor, along with its mobile cardiac telemetry services, is already available in the United States and the UK, marking a significant step in expanding access to advanced cardiac monitoring solutions [6] Market Prospects - The ECG devices market is projected to grow from $6.03 billion in 2024 to $14.5 billion by 2036, with a CAGR of 7%, driven by an aging population and increasing heart disease rates [7][8] - The demand for accurate cardiac diagnosis is reflected in the rising exports of ECG devices, indicating a robust growth trajectory for the industry [8] Recent Developments - The Zio monitor received CE mark certification under the EU's Medical Device Regulation, confirming its compliance with EU standards for performance, quality, safety, and efficacy [9] - The new Zio monitor features a thinner, lighter, and smaller design, improving patient wearability and compliance, and integrates with iRhythm's ZEUS AI algorithm for enhanced ECG data capture [10] Stock Performance - iRhythm Technologies' stock has declined by 32.3% this year, contrasting with the industry's 11.9% decline and the S&P 500's 17.2% increase [11]

SAN FRANCISCO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the company will present at the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, at 3:20 pm Eastern Time Wells Fargo 2024 Healthcare Conference on Thursday, September 5, at 8:45 am Eastern Time Baird 20 ...