recording an average of over 7 days of heart monitoring. Despite US FDA approval, the Zio Patch has met slow acceptance possibly due to reimbursement hurdles. Explanations for the slow acceptance ...

The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.

Rhythm Technologies, Inc. IRTC has received FDA 510(k) clearance for design changes and enhancements previously made to its ...

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...

Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...

Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) ...

FDA approves iRhythm's 510(k) submission for Zio AT device. A second approval may come soon, enhancing the company's mobile ...

Technologies announced that the results of the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk ...

Rhythm projects 2024 revenues of $580-$590 million but no profits, raising questions about long-term viability. Read more ...

The Zio AI continuous monitoring system combines a wearable electrocardiogram (ECG) patch, named the Zio AT ... on both symptomatic and asymptomatic heart events, continuously recording ECG ...

The system includes a patch, a wireless gateway ... Inc., enhancing its ambulatory cardiac monitoring offerings. iRhythm's Zio ECG monitoring system received regulatory approval from the Japanese ...