Another Rosenman Founder company receives Breakthrough Device Designation, this time Potrero Medical and their AKI Predict machine learning algorithm. This algorithm aims to enhance the clinical decision support at the bedsides of cardiac post-surgical intensive care patients by allowing for the advanced prediction of acute kidney injury. Congratulations to the Potrero Medical team on this milestone!
From the press release:
HAYWARD, Calif., Sept. 13, 2022 /PRNewswire/ — 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.
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.