FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method

Dascena Inc.’s GI Bleed Risk Alert System (Gibras) has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. 

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Gibras is a cloud-based software application that uses a machine learning algorithm to analyze patient electronic health record (EHR) data to aid in the early prediction of gastrointestinal bleeding (GIB) in adult patients in a hospital setting. In a preclinical study, Gibras was compared to the standard of care, Glasgow-Blatchford Bleeding Score (GBS). Using just the first two hours of patient data after admission into the hospital, Gibras outperformed GBS for predicting GIB and demonstrated higher sensitivity and specificity. 
 
“GIB is a common cause for hospitalization and unfortunately, is associated with significant morbidity and mortality,” said Ritankar Das, CEO of Dascena. “Our algorithm is designed to provide earlier prediction of GIB, allowing for timely interventions that could result in more favorable outcomes for patients. These predictions also provide clinicians with the opportunity to take preventative measures, such as weighing the benefits of discontinuing medications, like NSAIDS and anticoagulants, that are associated with GIB risk but may be prescribed for other clinical indications.” 

Dascena Inc. is a machine learning diagnostic algorithm company that is targeting early disease intervention to improve patient care outcomes.