Devices

Smiths Medical Recalls Tracheostomy Products

Smiths Medical is recalling (Class 1) specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. “If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which can lead to inadequate ventilation and increased risk of aspiration,” a recall notice says. To date, there have been 12 reported injuries.

The BLUselect tracheostomy tube is intended for adults who need an artificial airway after trauma or due to a medical condition. The BLUgriggs percutaneous dilation procedural tray and BLUperc percutaneous diliation procedural tray kits include additional procedural components to help healthcare providers with tracheostomy insertion.

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