AlgoDx
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.
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.”
Read more: AlgoDx receives CE mark for sepsis device
Dr. Enrico Petrillo, Brigham and Women’s Hospital Director of International Research and Strategic Initiatives, faculty Havard Medical School, Executive Director of Network Medicine Global Alliance, and Chairman of the Board AlgoDx added: “This FDA clearance is a pivotal moment for AlgoDx as we expand our presence in the United States. It validates our commitment to developing innovative technologies that address critical healthcare challenges. We look forward to bringing NAVOY CDS to health systems nationwide.”
Sepsis is the leading cause of in-hospital mortality worldwide according to AlgoDx, accounting for approximately 35% of all hospital deaths. Sepsis is a life-threatening condition caused by an extreme immune system response to an infection, and is a medical emergency that can lead to organ failure and death.
Early detection and treatment are crucial for improving a patient’s chance of surviving sepsis. AlgoDx says its solutions offer the potential to improve sepsis care by providing healthcare providers with a powerful tool to identify patients at risk in the Emergency Department as well as other hospital wards.
