AlgoDx receives CE mark for sepsis device

AlgoDx, a clinical stage medical device software company, has announced obtained the CE mark for NAVOY Sepsis. This medical device is intended to assist medical staff at Intensive Care Units (ICU) to predict sepsis in adult ICU patients.

Maria Sandvist, QA & operations manager, said: “We are proud to announce the CE conformity marking of our product NAVOY Sepsis. In addition to giving AlgoDx authorisation to commercialise the product within the EU, the CE mark further opens up opportunities for accelerated registration on other markets.”

NAVOY Sepsis is a prediction algorithm based on machine learning that, using only clinical variables routinely collected in Electronic Healthcare Records, predicts the risk of ICU patients developing sepsis in the coming hours.

Andreas Macura, chief product officer, added: “By obtaining the CE mark for NAVOY Sepsis, we hope to support the work of intensive care professionals with its comprehensive machine learning-powered sepsis prediction solution. The real benefits of 24/7 bedside monitoring of sepsis risk are the clinical implications of faster diagnosis and monitoring, given that, in sepsis treatment, the time factor is critical.”