Noninvasix’s Sepsis Monitoring Technology Designated a Breakthrough Device
Houston, Tex.-based Noninvasix’s LIVOx central venous oxygenation monitor has been designated a Breakthrough Device by the FDA.
The proposed indication is continuous or spot monitoring of central venous oxygen saturation in adults at risk of septic shock. Available methods for diagnosing low central venous oxygenation and monitoring treatment are either invasive or they do not measure it directly, the company noted.
The ability to measure central venous oxygenation noninvasively is “a serious unmet need” in healthcare, said Noninvasix CEO David Giarracco.