Devices

FDA Clears New LiveNova System Version

FDA says it cleared 2/25 a new version of the LivaNova heater-cooler system 3T that has changes to help reduce the risk of patient infections, including updated labeling with validated cleaning and disinfection instruction and the 3T aerosol collection set. Announcement of the clearance was included in an agency safety communication to remind healthcare providers and staff of ways to reduce the risk of cardiac surgery infection when using the LivaNova 3T system. The new communication updates a 10/2018 communication.

The 2018 notice said the company had issued a medical device correction letter giving updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that enough concentration is present to limit microbial growth and to announce the availability of the 3T aerosol collection set design upgrade to reduce, but not eliminate, the risk of potential emission of aerosols from the 3T system.

The latest safety communication contains recommendations for healthcare providers and staff.

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