FDA Accepts De Novo AlgoDx Sepis Detector

FDA has accepted for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult patients. The prediction algorithm software is based on machine learning that “accurately predicts the risk of ICU patients in developing sepsis in the coming hours,” the company says.

The device has been clinically validated in the “largest randomized clinical trial ever conducted with a sepsis prediction algorithm, and the software is approved for commercial use in the EU,” AlgoDx says. Its prediction algorithm uses only parameters that are routinely collected in high-acuity clinical information systems and electronic healthcare records, it adds.

Sepsis is a life-threatening infection that can damage multiple organs. It affects more than 30 million people worldwide annually and is responsible for around 6 million deaths, the company says.