Devices

FDA Breakthrough Status for Lupis Blood Purifier

FDA has granted Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant systemic lupus erythematosus. This is the second time the device has earned the designation, following earlier recognition for treating sepsis.

NucleoCapture is described as an extracorporeal apheresis column designed to filter cell-free DNA and neutrophil extracellular traps (NETs) from the bloodstream. NETs, webs of DNA and proteins released by white blood cells, are increasingly implicated in inflammation, thrombosis, autoimmunity, and organ injury, according to the company. By targeting this mechanism, Santersus aims to provide a non-immunosuppressive option for patients who have exhausted current therapies.

In its designation letter, the agency said the device may be used “as an adjunct to standard therapy in patients with severe or life-threatening and refractory systemic lupus erythematosus, who have active disease despite current standard of care treatment,” according to Santersus. The company says it is now preparing pivotal clinical trials in both the U.S. and Europe and is raising funds through a Series A financing round to support regulatory submissions and commercialization.

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