AlgoDx, a leading medical AI company with EU and UK-approved ML-based software for sepsis prediction in commercial use, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its sepsis detection software using a proprietary algorithm, NAVOY CDS. This milestone marks a major step forward in AlgoDx’s expansion into the U.S. market.
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NAVOY CDS is a software as a medical device (SaMD) designed to support clinicians in identifying sepsis in hospitalised patients, including the Emergency Department. By leveraging routinely collected vital parameters, the software analyses 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,” 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.”
