image credit: Freepik

FDA grants breakthrough status to Dascena’s AI for kidney injury

July 8, 2020


Machine learning diagnostic algorithm company Dascena has received breakthrough device designation from the US Food and Drug Administration (FDA) for Previse, an algorithm for the early detection of acute kidney injury (AKI).

The algorithm is designed to predict AKI in patients a day before patients meet the clinical criteria for diagnosis, the company noted.

A major challenge in the treatment of AKI is that the clinical criteria for diagnosis are markers of established kidney damage or impaired function.

Previse is expected to improve the treatment outcome by predicting whether a patient is likely to suffer from AKI before symptoms are present.