Potrero Medical Gets Breakthrough Device Nod for Accuryn AKI Predict Algorithm
Hayward, Calif.-based Potrero Medical received Breakthrough Device designation for its Accuryn AKI Predict machine learning algorithm for the advanced prediction of acute kidney injury associated with intra-abdominal hypertension in cardiac post-surgical intensive care patients.
The company developed the Accuryn system, which uses urinary catheters as diagnostic tools and provides real-time measurements of intra-abdominal pressure, urine output and core body temperature.
The system can be integrated into hospital electronic medical records.
The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, said the FDA.