Devices

FDA DrugSorb-ATR Options

FDA has suggested possible ways forward for CytoSorbents’ DrugSorb-ATR after denying the company’s appeal of the agency’s 4/25 denial of a de novo application for the antithrombotic removal system. In denying the appeal, FDA said it found no issues with device safety, a company statement says, but said additional information is needed to support the company’s requested indication.

“FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR,” the statement says, “and the company continues interactive discussions with the agency to seek further clarity on this proposal.” FDA also said the company could pursue its appeal with the CDRH director.

DrugSorb-ATR is described as an investigational device based on an equivalent polymer technology to the company’s CytoSorb to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received FDA breakthrough device designations for (1) the removal of ticagrelor and (2) the direct oral anticoagulants apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.

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