> ## 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.

# Biobeat 510(k) for Expanded Wearable Patient Monitor
- URL: https://www.fdaweb.com/biobeat-510-k-for-expanded-wearable-patient-monitor/
- Published: 2022-03-29T12:00:00.000Z
- Updated: 2026-09-14T17:38:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151475

FDA has cleared a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. The medical grade wearable monitors use proprietary non-invasive reflective photoplethysmography monitoring technology to automatically and continuously track multiple vital signs and health parameters, according to the company. “The wireless solutions connect to a cloud-based patient management system to provide medical staff with real-time data and alerts, enabling early identification of clinical deterioration,” it says. The management platform includes an automated early warning score system that uses advanced artificial intelligence-based algorithms that analyze aggregated patient data to identify deterioration more accurately and provide predictive analytics, it says.