Devices

Inflammatix Sepsis Molecular Diagnostic Cleared

FDA has cleared an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acute infection or sepsis. “Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status,” the company says.

The rapid blood test it designed to measure the expression levels of 29 genes associated with the host's immune response to infection. It uses “validated algorithms developed applying artificial intelligence (AI)/machine learning to interpret the host response information into three scores that indicate the likelihood of (1) bacterial infection, (2) viral infection, and (3) severe illness (as defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days),” the company says.

FDA cleared TriVerity based on data from the company’s SEPSIS-SHIELD study (NCT04094818), in which the test “yielded diagnostic and prognostic results with a high degree of accuracy in 1,222 enrolled patients across 22 sites, regardless of patients’ immune status or race,” Inflammatix 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

Read more

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