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# Empatica Adds 2 Biomarkers to Monitoring Device
- URL: https://www.fdaweb.com/empatica-adds-2-biomarkers-to-monitoring-device/
- Published: 2023-11-03T12:00:00.000Z
- Updated: 2026-09-14T14:15:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155721

FDA has cleared an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform — pulse and respiratory rate. “With the addition of pulse and respiratory rate, the [Empatica Health Monitoring Platform](https://www.empatica.com/platform/home/?ref=fdaweb.com) now includes six FDA-cleared digital biomarkers for use in clinical trials,” Empatica says. The device received its [initial FDA clearance 11/2022](https://www.empatica.com/blog/the-empatica-health-monitoring-platform-receives-fda-clearance.html?ref=fdaweb.com), which included monitoring for electrodermal activity, SpO2, skin temperature, and movement during sleep. “Beyond the FDA-cleared measures provided, the Empatica Health Monitoring Platform also offers access to raw data from the EmbracePlus sensors, and over 100 research-grade biomarkers,” the company says. Additionally, the platform includes Empatica’s proprietary [Care software suite](https://www.empatica.com/care/?ref=fdaweb.com), secure cloud infrastructure, and clinically validated digital biomarkers.