Devices

GI Bleed Alert System Gets Breakthrough Status

FDA has granted Dascena a breakthrough device designation for its GI Bleed Risk Alert System (Gibras), a cloud-based software application that uses a machine learning algorithm to analyze patient electronic health record data to aid in the early prediction of gastrointestinal bleeding (GIB) in adult patients in a hospital setting.

The algorithm is designed to provide earlier prediction of GIB than traditional diagnoses, allowing for timely interventions that could result in more favorable outcomes for patients, the company says. These predictions are intended to provide clinicians with the opportunity to take preventative measures, such as discontinuing medications like NSAIDS and anticoagulants that are associated with GIB risk but may be prescribed for other clinical indications, it adds.

In a preclinical study, the company says the device was compared to the standard of care, Glasgow-Blatchford Bleeding Score. “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,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome