Potrero Medical announced today that it received FDA breakthrough device designation for its AKI Predict machine learning algorithm.
Hayward, California-based Potrero designed its algorithm for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients.
The company developed the Accuryn system that uses urinary catheters as diagnostic tools. The device provides real-time measurements of intra-abdominal pressure, urine output and core body temperature. It can be integrated into hospital EMR systems.
“We celebrate the breakthrough designation, and we are excited about what this will mean for patients, providers and health systems in the future,” Potrero CEO Joe Urban said in a news release. “Continuous urine output and intra-abdominal pressure are new patient parameters that, until Accuryn, have not been available to leverage as critical data streams. Combining Accuryn technology with a predictive AKI algorithm will enhance the clinical decision support we provide at the bedside.”
The company closed a $26.6 million Series C funding round in July 2018 to help support the commercialization of Accuryn. It went on to raise nearly $5.5 million in equity in October 2019.