Sepsis, a severe reaction to infection causing widespread inflammation, can rapidly lead to organ damage and death, making it the primary cause of mortality within hospitals globally, contributing to around 35% of all hospital deaths. The key to combating sepsis lies in its early detection and prompt treatment. Although intensive care units (ICUs) generate vast amounts of data, which can make it difficult to spot some signs of patient deterioration in time, these environments are ideally suited for the application of artificial intelligence (AI) technologies. Now, an AI solution offers the potential to improve sepsis care by providing healthcare providers with a powerful tool to identify patients at risk in the Emergency Department (ED) as well as other hospital wards.

AlgoDx (Stockholm, Sweden) has introduced NAVOY CDS, a sepsis detection software using a proprietary algorithm, to support clinicians in identifying sepsis in hospitalized patients, including the ED. Utilizing a machine learning algorithm trained on data from over 60,000 ICU stays, NAVOY can predict the risk of sepsis up to three hours before traditional rule-based scoring systems, thereby facilitating earlier and more accurate clinical responses that can save lives and reduce healthcare expenses.

As a software as a medical device (SaMD), NAVOY continuously analyzes a range of vital signs, lab results, and other critical patient data gathered in the ICU, integrating seamlessly into existing Electronic Health Records (EHR) and Patient Data Management Systems (PDMS). This integration ensures that NAVOY’s predictions are readily accessible, providing clinicians with timely, actionable insights that enable swift interventions. With the latest U.S. Food and Drug Administration’s (FDA) 510(k) clearance, AlgoDx is set to extend its reach into the U.S. healthcare market, offering a significant advancement in the fight against hospital-acquired sepsis.

“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,” said Andreas Macura, Chief Product Officer at AlgoDx. “We believe that NAVOY CDS has the potential to significantly improve patient outcomes by enabling earlier detection and treatment of sepsis.”

“This FDA clearance is a pivotal moment for AlgoDx as we expand our presence in the United States,” added Dr. Enrico Petrillo, Chairman of the Board AlgoDx. “It validates our commitment to developing innovative technologies that address critical healthcare challenges. We look forward to bringing NAVOY CDS to health systems nationwide.” 

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