The US Food and Drug Administration (FDA) has issued 510(k) clearance for medical AI company AlgoDx’s sepsis detection software, NAVOY CDS.

The clearance paves the way for the company's expansion into the US healthcare market.

AlgoDx's NAVOY CDS is a software as a medical device (SaMD) that assists clinicians in the early identification of sepsis, a potentially fatal condition.

It operates by analysing routinely collected vital parameters, blood tests and other information of the patient already collected at the ICU, providing healthcare professionals with early warnings and the opportunity to intervene promptly.

AlgoDx chief product officer Andreas Macura said: “Receiving FDA clearance for NAVOY CDS is a testament to our team’s dedication and expertise in developing cutting-edge medical device software for healthcare.

“We believe that NAVOY CDS has the potential to significantly improve patient outcomes by enabling earlier detection and treatment of sepsis.”

The solution is already approved for use in the EU and UK, where it has been aiding in sepsis prediction.

NAVOY provides actionable, contextualised clinical inferences within EHR processes by anticipating sepsis with three hours of foresight, enabling practitioners to respond and intervene promptly.

In May 2024, Sweden-based Capio St Görans Hospital’s Intensive Care Unit deployed the solution to anticipate the early development of sepsis.

The technology integrates NAVOY and Philips’ Patient Data Management System (PDMS) IntelliSpace Critical Care and Anesthesia (ICCA) to provide a continuous patient sepsis risk monitoring option.

A condition caused by an extreme immune system response to an infection, sepsis is the leading cause of in-hospital mortality across the globe.