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AlgoDx announces FDA acceptance of De Novo application

The US Food and Drug Administration has accepted for review the company’s De Novo application for NAVOYÒ Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult ICU patients.

“We are proud to announce that our software NAVOYÒ has been accepted by the FDA for substantive review through the De Novo classification process, which confirms the status of NAVOY as the first such product in line to attain FDA clearance. We are looking forward to collaborating with the FDA throughout this process,” says Andreas Macura, Chief Product Officer and QA at AlgoDx.


NAVOYÒ is a prediction algorithm software based on machine learning that accurately predicts the risk of ICU patients in developing sepsis the coming hours. NAVOYÒ 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’s solution lies in the deployment of a machine learning-based prediction algorithm that, using only parameters that are routinely collected in high-acuity clinical information systems and electronic healthcare records. As such, NAVOYÒ autonomously and continuously predicts sepsis risk in ICU patients to assist healthcare provider with early sepsis detection.

“This is a major milestone for us, as we continue to support ICU providers in the US by delivering value-based care through integrated solutions that support providers in detecting sepsis in a timely manner,” says David Becedas, CEO. “A positive outcome from the FDA will differentiate our clinical decision support software from non-vetted products.”

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