Devices

FDA Clears Thermo Fischer Antimicrobial Susceptibility Plate

FDA has cleared a Thermo Fisher Scientific 510(k) for its microbroth dilution plate for antimicrobial susceptibility of Gram negative organisms, including two of the latest novel compounds — ceftolozane/tazobactam and ceftazidime/avibactam. The plate enables microbiology laboratories to measure true minimum inhibitory concentration (MIC) values of 24 antimicrobials, which are critical in reducing antimicrobial resistance, according to the company. “True MIC values are also the best measure of antibacterial effect, which can assist with therapeutic choices and promote overall better patient care,” it says.

Thermo Fisher says the Sensititre Gram Negative GN6F Plate can be read using a range of options, from manual methods to full automation. It also includes a range of standard plates, as well as the ability to create custom plates tailored to a lab’s formulary, dilution ranges and patient population, eliminating offline tests and reducing costs.

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