Drugs

BC3 Tech Clears SEAL Rapid Wound Spray

FDA has cleared a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray, described as an aerosolized chitosan for rapidly addressing serious arterial bleeding. “When sprayed on a bleeding wound, SEAL quickly forms a strong barrier that helps stop bleeding within seconds and without pain,” the company says. “SEAL can be used by first responders, in surgical environments, or in battlefield combat.” Device aerosol containers come in two sizes: a three-second can for stab and bullet wounds and a 10-second can for wounds larger than four inches or for appendages that have been severed.

The clearance was based on data from a pivotal study showing the device was therapeutically equivalent to other chitosan-based products indicated for hemorrhage. “Use of SEAL resulted in 50 percent less blood loss than other chitosan-based dressings or granules,” BC3 Tech says. “Its proprietary aerosol delivery system – unique in the class – helps to stop the bleeding rapidly and effectively, and it reduces the risk of wound infections by preventing the growth of harmful bacteria.”

BC3 Tech describes Chitosan as a linear polysaccharide composed of randomly distributed β-linked D-glucosamine and N-acetyl-D-glucosamine. It is intended to adhere to fibrinogen, which produces increased platelet adhesion that results in blood clotting/hemostasis.

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