Drugs

Teleflex QuikClot Device Expanded Use Cleared

FDA has cleared a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device — mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. The company says the expanded use now allows physicians to use the device to control all bleeding in cardiac surgical procedures. The clearance also expanded its use to include patients on anticoagulation/antiplatelet medication, use with or without autotransfusion (blood salvage) equipment, and use with or without cardiopulmonary bypass systems, according to Teleflex.

The clearance is based on data from the company’s 2021 cardiac study, which it says examined the percentage of patients who achieved hemostasis in the first 10 minutes of hemostatic application and compression at the bleeding site. The study “concluded that the QuikClot Control+ Hemostatic Device was superior to standard gauze in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding,” it says. “Additionally, there was no significant difference in safety outcomes. Study participants receiving the QuikClot Control+ Hemostatic Device achieved hemostasis at more than 20% higher proportion at both 5 and 10 minute intervals when compared to those receiving standard gauze.”

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