Dascena announced today that it received FDA breakthrough device designation for its Previse algorithm for predicting acute kidney injury (AKI).
The artificial intelligence (AI)-based algorithm is designed to predict AKI more than a full day before patients meet the clinical criteria for diagnosis. The company touts its regulatory victory as the first breakthrough nod for a cloud-based machine learning algorithm developed for the early detection of AKI.
In validation studies, Previse demonstrated higher sensitivity and predictive value than a clinician’s assessment based on clinical criteria, while only utilizing patient data that were already routinely collected, according to a news release.
Oakland, Calif.-based Dascena said that a 2018 paper published in the Canadian Journal of Kidney Health and Disease reported that Previse predicted AKI 48 hours before onset with 84% accuracy and a diagnostic odds ratio of 5.8.
“Acute kidney injury comm…