Devices

FDA Approves AvertD Opioid Use Test

FDA has approved AutoGenomics’ AvertD, the first test that uses DNA to assess whether certain individuals may have an increased risk of developing opioid use disorder. CDRH director Jeffrey Shuren says the AvertD test is intended to be used before the first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription to treat acute pain, such as in patients scheduled to undergo a planned surgical procedure.

The prescription-only test is to be used only with patients who consent to it and have no prior use of oral opioid analgesics, Shuren says. “AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” he says.

As part of the FDA approval, AutoGenomic must train healthcare providers to help ensure appropriate use of the test. It also must conduct a large post-market study assessing device performance in patients, regularly reporting to FDA its progress toward completing the study.

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