> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Cardiac Insight Gains Clearance for ECG Sensor
- URL: https://www.fdaweb.com/cardiac-insight-gains-clearance-for-ecg-sensor/
- Published: 2017-04-20T12:00:00.000Z
- Updated: 2026-09-14T22:18:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138493

FDA has cleared a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo. The device offers physicians immediate access to real-time reporting and analysis of heartbeat-to-heartbeat data. It is intended to be used to assist with diagnosing a variety of arrhythmias, including the most common, atrial fibrillation. The sensor’s technology eliminates the need for outsourcing to costly and time-consuming third-party service centers and puts control of the patient data, analysis and processing in the hands of physicians and their staff, the company says.