HAYWARD, Calif., Sept. 13, 2022 – Potrero Medical announced today that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients.
“We are excited about the designation, and what this means for patients, providers and health systems” Joe Urban, CEO
Joe Urban, Potrero CEO stated “We celebrate the breakthrough designation, and we are excited about what this will mean for patients, providers and health systems in the future.” Urban further commented “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.”
To receive breakthrough designation from the FDA, there are several criteria that must be met. First, the device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Next, the device must meet one of the following: 2a) it represents breakthrough technology, 2b) no approved or cleared alternative exists, 2c) it offers significant advantages over existing approved or cleared alternatives, or 2d) device availability is in the best interest of patients.
About Potrero Medical
Potrero Medical, Inc. is a personalized platform transforming patient care through precision fluid management and analytics that offer clinical decision support by providing precise data from the kidney. Potrero Medical was founded with a mission to improve patient care and save health systems money with the latest advances in artificial intelligence and sensors. Potrero Medical is headquartered in Hayward, CA. For more information, visit potreromed.com