Devices

FDA Clears Strata Skin Sciences Laser Dose Tip

FDA has cleared a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser. The accessory is indicated for use in conjunction with the laser to filter narrow band-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient being treated for psoriatic plaque. The tip accessory simultaneously applies multiple level doses of energy to a specific area of a patient’s psoriatic plaque, thereby identifying the maximum sub-blistering energy dose for a particular treatment zone, the company says. “Utilizing the results from these test patches, the physician can design the optimal therapeutic dose treatment for each patient,” it adds. “The optimization of the dose levels should result in a shorter treatment regimen to achieve clearance.”

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