Devices

FDA Green Lights At-Home Sexual Disease Test

FDA has granted Visby Medical a de novo marketing clearance for its Women’s Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, gonorrhea and trichomoniasis. The single-use device includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to Visby’s Medical App, according to the company. Results are available within 30 minutes and displayed on the app.

“In individuals with and without symptoms, the Visby Medical Women’s Sexual Health Test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples,” an FDA release 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