Noninvasix has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its non-invasive monitoring technology for sepsis.

The breakthrough status has been granted to LIVOx Central Venous Oxygenation Monitor , which allows non-invasive, real-time, continuous or spot monitoring of central venous oxygen saturation (ScvO2) in people at risk of septic shock.

Noninvasix CEO David Giarracco said: “The Breakthrough Device Designation validates the company’s focus to monitor patients with sepsis by measuring central venous oxygenation non-invasively, addressing a serious unmet need in healthcare.

“Measuring ScvO2 non-invasively will open new paths to more efficient and earlier diagnosis of septic shock, enabling better patient care and reducing healthcare costs.

“This milestone marks the beginning of future developments, enhancements, and evidence to expand the use and clinical impact of our technology into other indications and settings. We are dedicated to making a difference in a major issue in healthcare.”

Noninvasix claims to be the first firm to facilitate non-invasive monitoring of sepsis through early identification of the crucial indication of septic shock, thereby helping in reducing complications.

Currently, the available methods for diagnosis of low Scv02 and monitoring treatment are non-invasive but they measure Scv02 indirectly with less sensitivity and specificity for diagnosis.

The LIVOx Central Venous Oxygenation Monitor is designed to help doctors diagnose this life-threatening illness more effectively.

The company’s optoacoustic platform includes disposable patient interface, reusable probe, data display and hardware.

Designed to be worn on the patient’s chest, the probe allows continuous monitoring of venous oxygen saturation levels in real time.

According to the company, the monitor is used to target specific blood vessels based on the desired metric.