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# CardiacSense Vital Signs Watch Cleared by FDA
- URL: https://www.fdaweb.com/cardiacsense-vital-signs-watch-cleared-by-fda/
- Published: 2023-01-09T12:00:00.000Z
- Updated: 2026-09-14T18:11:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153500

FDA has cleared a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen saturation of arterial hemoglobin. During 2023, the company says it plans to submit additional data to the agency to support additional intended uses.

“Motion artifacts are the key problem plaguing other \[photo-plethysmography\] PPG-based systems,” which are used to measure pulse rate, the company says. “We have developed proprietary hardware, including a novel motion artifact sensor, which identify and cancel out motion artifacts thereby leaving us with a pure biometric signal for accurate vital sign monitoring. Clinical data submitted to the FDA demonstrated sensitivity and specificity of 99.6% for beat-by-beat heart rate when compared to Holter Monitor.”