iRhythm Technologies today announced new research emphasizing the clinical and health-economic advantages of its Zio long-term continuous monitoring (LTCM) system. Five studies showed the impact of digital engagement tools, arrhythmia patterns during sleep and activity, and the economic potential of early arrhythmia detection for patients with chronic conditions like type 2 diabetes and COPD. The […]
iRhythm Technologies
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates. San Francisco-based iRhythm submitted two updates to the mobile cardiac telemetry device following an FDA warning letter last year. The letter, made public shortly after the company’s announcement, accused iRhythm of violations related to rules for labeling, quality […]
iRhythm stock soars on FDA nod for changes to Zio AT following warning letter
iRhythm Technologies has received FDA 510(k) clearance related to design changes made to its Zio AT device. The news yesterday has set shares of IRTC up 25% for the week. As of midday today, they’re trading at $75.76 apiece. San Francisco-based iRhythm received the clearance for prior design changes via letter to file. Zio AT remains […]
iRhythm wins regulatory nod in Japan for Zio ECG
iRhythm Technologies announced that it received approval in Japan for its Zio long-term continuous monitoring (LTCM) system. The Japanese Pharmaceutical and Medical Device Agency (PMDA) approved the 14-day wearable ECG system. San Francisco-based iRhythm now plans to work toward a reimbursement decision for Zio with the Japanese Ministry of Health, Labour, and Welfare (MHLW). The […]
iRhythm has positive post-market study results for next-gen Zio
iRhythm Technologies today announced initial research findings on its Zio monitor’s post-market, real-world performance. The company presented the data on its next-generation long-term continuous monitoring (LTCM) patch ECG device at Heart Rhythm Society’s HRX 2024 meeting. Zio builds on the previous-generation Zio XT with long-term, continuous cardiac monitoring for up to 14 days. It provides […]
iRhythm enters licensing deal for BioIntelliSense sensor tech
iRhythm Technologies announced today that it signed an exclusive license agreement with BioIntelliSense to develop and commercialize cardiac monitoring technology. The deal centers around certain patented technology assets within ambulatory cardiac monitoring (ACM). iRhythm aims to utilize BioIntelliSense’s multiparameter sensing technologies to expand the capabilities of its own platform. “We believe that the licensed technology […]
iRhythm expands Zio’s reach with multiple launches in Europe
iRhythm Technologies announced today that it launched its Zio ECG monitoring services in a number of European countries. San Francisco-based iRhythm launched its Zio monitor and Zio long-term continuous (LTCM) ambulatory ECG monitoring service in Austria, the Netherlands, Spain and Switzerland. The technology, along with the supporting Zeus AI algorithm, picked up CE mark at […]
iRhythm stock is down on news of more FDA inspection issues
Wearable heart monitor company iRhythm saw its stock fall today on news of additional FDA inspection issues and a surprise CFO exit. IRTC shares were down more than 10% to $75.68 apeice by midday trading today. MassDevice‘s Medtech 100 Index was down half a percent. The disclosures, which came after market close yesterday, accompanied a […]
iRhythm posts Street-beating revenues in Q1, FDA warning letter remains on track
iRhythm shares dipped slightly today on first-quarter results that topped the consensus sales forecast. Shares of IRTC fell 1.7% to $108.96 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly. The San Francisco-based cardiac monitoring technology maker reported losses of $45.7 […]
iRhythm closes offering worth more than $660M
iRhythm announced today that it closed an offering of senior notes worth gross proceeds of $661.25 million. The San Francisco-based cardiac monitor maker said earlier this week that it intends to offer $450 million in convertible senior notes. Approximately 17 hours later, it upsized that offering to a base of $575 million. San Francisco–based iRhythm […]
iRhythm proposes $450M offering
iRhythm announced today that it intends to offer $450 million in convertible senior notes. San Francisco–based iRhythm plans to offer the notes — due 2029 — to qualified institutional buyers. It intends to grant initial purchasers a 13-day option to buy up to an additional $67.5 million in notes. The notes will be senior, unsecured […]
