Devices

FDA Says Galemed Babi.Plus Recall Class 1

FDA says the 6/14/19 Teleflex recall of 14,964 units of the Galemed Babi.Plus 12.5 cm H₂O pressure relief manifold is Class 1. An agency notice says the affected units were distributed between 10/2018 and 5/2019.

The device is used as part of a breathing circuit designed to assist the breathing of infant patients who weigh no more than 10 kilograms. The distributor Teleflex recalled the units because they do not hold pressure when initially set up on a patient, FDA says. The issue is due to a dislodged valve not being properly seated, resulting in loss of pressure in the system.

The notice says that the use of the affected devices may cause serious adverse health consequences, including lower blood oxygen levels, slow heart rate, apnea, rebreathing of exhaled carbon dioxide by the patient, and need for medical intervention and resuscitation.

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