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 ...

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 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 ...

文章核心观点 - iRhythm Technologies (IRTC)公司最新推出的Zio LTCM监测设备在实际使用中表现优于前代产品Zio XT [1][2][3] - Zio LTCM监测设备的设计改进,如防水外壳和新型透气粘合剂,提高了设备的佩戴时长和可分析时长,有助于提高患者依从性和心律失常检测率 [2][3] - Zio LTCM监测设备在美国已有超过100万患者使用,占iRhythm公司LTCM注册量的近70% [4] - iRhythm公司还在奥地利、荷兰、西班牙和瑞士推出了Zio LTCM监测服务 [4] 行业分析 - 根据Grand View Research的报告,2022年全球可穿戴心脏监测市场规模为58亿美元,预计2023-2030年将以10.4%的复合年增长率增长 [5] - Zio LTCM监测设备的优异表现有望为iRhythm公司的业务带来提振 [5] 公司表现 - 过去6个月内,iRhythm公司股价下跌34.7%,而同期标准普尔500指数上涨7.1%,行业下跌17.5% [6] - iRhythm公司目前的Zacks评级为3级(持有) [7] - 同行业中,Universal Health Service、Quest Diagnostics和ABM Industries的股价表现较好,Zacks评级为1级(强烈买入)和2级(买入) [7][8]

iRhythm Technologies (IRTC) recently announced that it had signed an exclusive license agreement with BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, to develop and commercialize certain patented technology assets within ambulatory cardiac monitoring (ACM). With the agreement, it is likely to utilize BioIntelliSense's multiparameter sensing technologies to expand the capabilities of its platform. IRTC's management believes that the licensed technology from BioIntelli ...

文章核心观点 - 公司的下一代Zio®监测设备在佩戴时间和可分析时间方面表现优于前一代Zio®XT设备 [1][2][3] - 更长的佩戴时间和可分析时间可能进一步提高诊断产出,建立在Zio XT服务在门诊心脏监测服务中优异产出的基础之上,这在之前的CAMELOT研究中已有证明 [1][4] - 自2023年底推出以来,Zio监测设备已被超过100万名患者使用 [1][7] 根据目录分别总结 设备性能 - 新一代Zio监测设备佩戴时间短于48小时的情况更少(1.1% vs 2.8%, p<0.0001) [3][5] - 新设备平均佩戴时间更长(12.6 vs. 11.9天, p<0.0001) [3][5] - 新设备平均可分析时间更长(12.2 vs 11.5天, p<0.0001) [3][5] - 新设备皮肤刺激报告更少(0.47% vs 1.35%, p<0.0001) [5] 诊断产出 - 新设备对阵发性房颤的检出率更高(8.7% vs 6.8%, p<0.0001) [3][5] - 新设备对总体心律失常检出率更高(80.9% vs 76.4%, p<0.0001) [3][5] 市场表现 - 自2023年9月在美国推出新一代Zio监测设备和升级的Zio服务以来,Zio监测设备已被超过100万名患者使用,占iRhythm美国长期连续监测注册量的近70% [7] - iRhythm最近还在奥地利、荷兰、西班牙和瑞士推出了Zio®监测设备和Zio®长期连续监测服务 [7]

文章核心观点 - 该研究是一项大规模的随机对照试验,旨在评估利用iRhythm的Zio® XT长期连续监测(LTCM)设备进行无症状房颤筛查对降低中风发生率的影响[1][2][3] - 该研究发现,使用Zio® XT LTCM进行筛查可以增加新诊断房颤的比例(5.0%vs3.3%),但未能显示对中风发生率的降低,这可能与样本量不足和随访时间缩短有关[4] - 该研究表明,在初级保健环境中采用基于贴片的远程监测是可行的,并且可以发现大部分患者存在短暂、间歇性的房颤,这可能需要更积极的心脏病风险因素管理[4] 关键要点总结 筛查结果 - 使用Zio® XT LTCM进行筛查,新诊断房颤的比例较常规护理组有所增加(5.0%vs3.3%)[4] - 筛查组开始使用抗凝药物的比例也有所增加(4.2%vs2.8%),但出血住院率没有增加[3] 研究实施 - 这是迄今为止最大规模的评估基于初级保健的房颤筛查的随机对照试验,参与者中超过一半为女性[3] - 20%的参与者通过虚拟方式参与,自行在家佩戴Zio® XT LTCM设备,佩戴时间和可分析时间与临床佩戴组相似[3] 房颤特点 - 在252例检测出房颤的参与者中,大部分(88%)为阵发性房颤,且多数(88%)房颤占监测时间不到1%[4] - 这表明,仅依靠12导联心电图(10秒)、智能手表心电图(30秒)或48小时动态监测等较短时间的监测,很容易错过这些短暂、间歇性的房颤[4]

iRhythm Technologies, Inc. (IRTC) has officially launched its Zio monitor and long-term continuous (LTCM) ECG monitoring service in Austria, the Netherlands, Spain and Switzerland. With CE mark certification under EU's Medical Device Regulation (MDR), the Zio monitor offers up to 14 days of uninterrupted ECG monitoring. This launch underscores iRhythm's commitment to delivering patient-centered digital healthcare solutions globally. Significance of IRTC's Zio Monitor Cardiac arrhythmias involve irregular he ...

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 ...