Devices

2 NICO Brain Surgery Devices Cleared by FDA

FDA has cleared two devices made by NICO Corp. that are used in a new approach to brain surgery. NICO received 510(k) clearance for specific neurosurgical indications on its Myriad automated tissue removal handpiece. The new clearance provides specific disease state approval for primary and secondary brain tumors, vascular abnormalities and malformations, and intraventricular tumors and cysts, according to the company. NICO also received an updated clearance for its BrainPath access device, which is now cleared for use in specific disease states such as high grade gliomas and glioblastoma multiforme, secondary metastatic tumors, and vascular abnormalities like intracerebral hemorrhage.

Myriad is an automated, multi-functional tool used for precise resection, suction, clot evacuation and tumor removal in neurosurgery, spinal surgery, ENT and otolaryngology, NICO says. BrainPath allows a surgical approach to remove tumors through smaller exposures and with minimal manipulation of the normal brain anatomy, it adds.

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