Devices

FDA Clears Irvine Scientific Expanded Use for Fertility Kit

FDA has cleared an Irvine Scientific 510(k) for expanded use of its Vit Kit vitrification media to include human oocytes. The company says it is the first to obtain such a clearance. Its Vit Kit-Freeze and Vit Kit-Thaw are now intended for use with oocytes, pronuclear zygotes through day three cleavage-stage embryos and blastocyst-stage embryos. Vitrification is a cryopreservation technique that Irvine Scientific says provides “excellent survivability of embryos and oocytes through dehydration and ultra-rapid cooling. This process eliminates the concerns of damaging ice-crystal formation associated with traditional slow freezing. The ability to offer an FDA-cleared vitrification media for oocytes will enhance the ability of fertility clinics to preserve women’s fertility through oocyte freezing.”

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