Noninvasix Granted the US FDA Breakthrough Device Designation for Non-Invasive Monitoring Technology for Sepsis
On February 23, 2022, Noninvasix, Inc. received the US FDA breakthrough device designation for its LIVOx™ Central Venous Oxygenation Monitor. It is a non-invasive device and provides real-time, continuous, or spot monitoring of central venous oxygen saturation (ScvO2) in adults at risk of septic shock.
At present there are no non-invasive approaches available that can efficiently provide ScvO2 information with high sensitivity and specificity, nevertheless, Noninvasix will be the first company to non-invasively monitor sepsis by detecting ...