Devices

Olympus 510(k) for EZ Shot 3 Plus Needle Cleared

FDA has cleared an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The product line has designed to be used with an Olympus endoscopic ultrasound system (EUS) for ultrasonically guided FNA and FNB of submucosal and extramural lesions within the gastrointesitnal tract (i.e. pancreative masses, mediastinal masses, perirectal masses and lymph nodes), the company says. “FNB is an important advantage for physicians because it has been reported that the larger tissue samples it provides may enable more precise diagnosis and rapid cytodiagnosis, a technique for on-the-spot pathological diagnosis of tissues collected during surgery,” it 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