U.S. Food and Drug Administration granted breakthrough-device designation to Dascena Inc's algorithm that helps predict acute kidney injury in patients before clinical diagnosis.
Acute kidney injury is an abrupt loss of kidney function due to sudden damage. It occurs as a complication to other serious illnesses, and the impact can range from the return of organ function after a while to complete kidney failure.
Dascena's Previse is a cloud-based machine learning algorithm that is designed to detect acute kidney injury at an earlier stage. The program has shown higher sensitivity and predictive value compared to a doctor's assessment based on clinical criteria, according to a July 7 news release.
The designation will allow for expedited approval of the device, as it may provide more effective treatment of life-threatening or irreversibly debilitating diseases.
Oakland, Calif.-based Dascena is a private healthcare technology company that develops algorithm software for diagnostics and biomarkers.