Devices

FDA Grants de novo Petition for Pheno System

FDA has granted a de novo petition request to allow marketing of Accelerate Diagnostics’ Pheno system and PhenoTest BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis. “With the Accelerate PhenoTest(TM) BC kit, labs can reduce the turnaround time by testing directly from positive blood culture samples, producing results up to 40 hours faster than conventional methods,” the company says.

The multiplexed in vitro diagnostic test uses both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility testing methods. “The blood culture kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms using morphokinetic cellular analysis (MCA) of individual microbial cells and colonies under the challenge of antibiotics,” Accelerate Diagnostics says.

Marketing authorization was based on data from a clinical study including more than 39,000 tests conducted on 1,850 samples across 13 trial sites. “The study showed overall sensitivity of 97.4% and specificity of 99.3% for identification,” the company says.

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