Devices

Bladder Cancer Test Gets Breakthrough Status

FDA has granted AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection. The test is intended as an alternative to traditional cystoscopy. It is designed to detect bladder cancer through random urine collection and conducting methylation detection of exfoliated cell DNA in the urine.

“The performance of the test has shown to be as strong as that of cystoscopy, and significantly better than exfoliative cytology and fluorescence in situ hybridization in the detection of early and non-muscle invasive bladder cancer,” the company says.

The test demonstrates increased advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer, according to the company. The designation is based on data showing the test’s accuracy, sensitivity and specificity at 89.3%, 87.4% and 91.5%, respectively.

Currently, the company is planning a clinical trial in the U.S. to obtain data to support a marketing authorization.

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