named the Zio AT patch, with the ZEUS system, iRhythm’s AI-powered software for ECG analysis. This latest update comes after the FDA issued a warning letter to iRhythm regarding the device ...
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
The Zio AT wireless patch device is cleared by the FDA for ... According to the FDA’s May 2023 warning letter, iRhythm began marketing Zio AT as a mobile cardiac telemetry monitor intended ...
15d
Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) ...
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
FDA clears iRhythm's first 510(k) submission for Zio AT device; second approval expected soon. Zio AT provides mobile cardiac telemetry for up to 14 days, aiding in ECG monitoring. On Monday, the ...
iRhythm's stock surged over 20% today after the FDA cleared its 510(k) submission for the Zio AT device, despite ongoing regulatory challenges. The company still faces significant hurdles ...
Artisan Partners, an investment management company, released its “Artisan Mid Cap Fund” third quarter 2024 investor letter. A ...
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and ...
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