Devices

Sepsis Risk Assessment Test Gets Breakthrough Status

FDA has granted MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments in patients suspected of developing sepsis. The test is designed to “aid clinicians in rapid risk stratification and predicting disease progression, in conjunction with clinical assessments and other laboratory findings,” according to the company.

MeMed says its test is based on “advanced host-response technology” that measures multiple proteins from a blood sample and uses machine learning to stratify the risk of a patient with a suspected acute infection deteriorating to severe outcomes within 72 hours or death within 14 days. It is intended for emergency department settings, and it has the potential to assist clinicians in identifying who could benefit from escalated care and who might be safely discharged from the hospital, it says. The test is said to be compatible with high-throughput analyzers using minimal blood volume requirements, with results provided in 15 minutes.

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