Medical artificial intelligence (AI) company AlgoDx has received 510(k) clearance from the US Food and Drug Administration (FDA) for its sepsis detection software, NAVOY CDS.
AlgoDx had developed machine learning software for sepsis prediction, which is approved in the European Union (EU) and the UK. The latest regulatory milestone will enable the AI firm to enter the US market.
NAVOY CDS is software as a medical device (SaMD) designed to assist clinicians in detecting sepsis in hospitalised patients, including those in the emergency department.
By analysing routinely collected vital signs, the software provides early warnings of sepsis, a serious condition, enabling healthcare providers to take timely action.
It uses a combination of 20 parameters, including vital signs, blood gas tests, lab values, gender, and age, which are automatically pulled from the ICU patient data system.
The device received the CE mark in May 2021.
AlgoDx chief product officer Andreas Macura said: “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.
“We believe that NAVOY CDS has the potential to significantly improve patient outcomes by enabling earlier detection and treatment of sepsis.”
Sepsis is a life-threatening condition due to a severe reaction to an infection that can lead to organ failure and death. Early detection and treatment are essential for survival, AlgoDx said.
The AI firm’s solutions can help improve sepsis care by giving healthcare providers a powerful tool to identify at-risk patients in every hospital area.
In May this year, AlgoDx partnered with Philips to advance sepsis detection in the intensive care unit (ICU) of Sweden-based Capio St Göran’s Hospital.
Under the partnership, NAVOY software will be integrated with Philips’ patient data management system (PDMS) IntelliSpace Critical Care and Anesthesia (ICCA) to provide a continuous sepsis risk monitoring option for healthcare providers.
The sepsis prediction-focused firm is also developing a portfolio of novel machine-learning algorithms for acute kidney injury, inflammatory bowel disease, and hepatitis B.
