AlgoDx has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its sepsis detection software using an algorithm, NAVOY CDS.
This milestone marks a major step forward in AlgoDx’s expansion into the U.S. market, states the company.
NAVOY CDS
NAVOY CDS is a software as a medical device (SaMD) designed to support clinicians in identifying sepsis in hospitalized patients, including the Emergency Department. By leveraging routinely collected vital parameters, the software analyzes patient data to provide early warnings of sepsis, a life-threatening condition, enabling healthcare providers to initiate timely interventions.
“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,” says 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.”
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