CardiacSense Ltd

CardiacSense receives FDA Clearance for Medical Watch

Retrieved on: 
Monday, January 9, 2023
Arrhythmia, COPD, MDR, Atrial fibrillation, Motion, Blood pressure, Artifact, Respiratory rate, Oxygen, CardiacSense Ltd, CE, Oxygen saturation (medicine), Tel Aviv Sourasky Medical Center, Patient, Holter monitor, FDA, Vital signs, Heart failure, PPG, Pharmaceutical industry, Medical device

CardiacSense was granted FDA clearance for Beat-by-Beat Heart Rate, and Oxygen Saturation (SpO2)

Key Points: 
  • CardiacSense was granted FDA clearance for Beat-by-Beat Heart Rate, and Oxygen Saturation (SpO2)
    CAESAREA, Israel, Jan. 9, 2023 /PRNewswire/ -- CardiacSense Ltd ., a digital health company that developed the world's most advanced, medically certified wearable device for monitoring vital signs announced receipt of U.S.A. Food and Drug Administration (FDA) clearance of its CSF-3 watch for measuring Beat-by-beat Heart Rate, and Oxygen Saturation of Arterial Hemoglobin (SpO2).
  • Leveraging the CE mark, CardiacSense has begun commercialization of the medical grade CSF-3 watch in a dozen countries across Europe, Asia and South America.
  • Eldad Shemesh, CardiacSense Founder and CEO commented that "Motion artifacts are the key problem plaguing other PPG based systems.
  • With approval of these indications, CardiacSense will become the company with the largest number of regulatory-approved medical indications for a wearable device.