Devices

Braun Introcan Deep Access Catheter Cleared

FDA has cleared a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter, the newest addition to the company’s Introcan portfolio. The device provides automatic passive safety needlestick protection and multi-access blood control in longer lengths than its earlier version of the device, according to the company. It is also designed to access deeper veins in patients with difficult vascular access and to achieve longer dwell times, B. Braun says.

It says the device has been shown to significantly increase peripheral intravenous catheter (PIVC) dwell times to about 5.7 days versus 3.8 days for standard long PIVCs. Longer dwell times help reduce PIVC restarts and help reduce escalation to more costly, invasive devices such as peripherally inserted central catheters, it says. “The multi-access blood control hub in the Introcan Safety 2 Deep Access PIVC is designed to minimize blood exposure and reduce the need for cleanup of blood throughout IV therapy, and there is no need to occlude the vessel during insertion or any time the hub is accessed,” it adds.

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