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# VivaQuant RX-1 Wearable ECG Monitor Cleared
- URL: https://www.fdaweb.com/vivaquant-rx-1-wearable-ecg-monitor-cleared/
- Published: 2019-04-30T12:00:00.000Z
- Updated: 2026-09-15T01:23:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143988

FDA has cleared a VivaQuant 510(k) for its RX-1 wearable device, which is intended to continuously monitor a patient’s ECG and identify arrhythmias. Collected data from the wearable is communicated to the cloud using a built-in cellular connection, the company says. “Skilled staff in a U.S.-based monitoring center review the incoming data and report clinically important information to the patient’s physician,” it says.

The device uses VivaQuant’s patented wavelet-based analytics and embedded artificial intelligence to extract information more quickly, accurately, and efficiently than traditional technologies, according to the company. The small one-piece device can be worn in the shower, and it can operate as a mobile cardiac telemetry device, event recorder, or Holter monitor.