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 commonly affects hospitalized individuals, and if not caught early, can result in dangerous outcomes for patients,” Dascena CEO Ritankar Das said in the release. “Our machine learning algorithm is able to analyze patient vital sign data and determine whether a patient is at risk of developing acute kidney injury. With this technology, we believe we’ll be able to provide physicians with ample time to intervene and prevent long-term kidney injury in their patients.”