Devices

FDA Says ACIST Recall of Kodama Catheter is Class 1

FDA says a 1/18 recall of the ACIST Kodama intravascular ultrasound catheter due to risk of broken O-ring pieces flushing into arteries during use is Class 1. The device uses ultrasound waves to view the inside of an artery, including its structure, and any devices such as stents. An agency notice says 490 units that were distributed between 11/10/20 and 1/14/21 were recalled.

The company says the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, it says, pieces of the O-ring may break free and flush into the patient’s artery during use. “This could cause serious patient harm including vessel blockage, heart attack, heart arrhythmia, or stroke, with associated chest pain or discomfort,” the agency notice says.

FDA says there have been no complaints, injuries, or deaths reported.

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

Read more

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