iRhythm Technologies Receives FDA 510(k) Clearance for Design Modifications to Its Zio® AT Device
iRhythm Technologies, Inc. (IRTC)
Last irhythm technologies, inc. earnings: 2/27 04:05 pm
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Source: GlobeNewswire
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 Administration (FDA) has granted clearance for its 510(k) submission related to design modifications and labeling updates for the Zio AT device. Zio AT remains commercially available on the market to ship to customers in the United States, and product enhancements subject to this 510(k) clearance will be available in 2025. “This clearance is related to enhancements to our Zio AT product, including design features and labeling updates intended to address areas of concern specifi
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- Here's Why iRhythm Technologies (IRTC) Slid in Q3 [Yahoo! Finance]Yahoo! Finance
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Earnings
- 10/30/24 - Miss
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Sec Filings
- 11/14/24 - Form 8-K
- 11/12/24 - Form SC
- 11/12/24 - Form SC
- IRTC's page on the SEC website