Devices

FDA Panel Knocks Down Ischemic Stroke Device

FDA’s Medical Devices Advisory Committee’s Neurological Devices Panel has voted 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate the device’s benefits outweigh its risks. The company is seeking an indication for increasing cerebral blood flow and to reduce disability in adult patients with acute ischemic stroke with confirmed cortical involvement in the anterior circulation.

Panel members agreed with an agency briefing document that raised concerns about several significant changes in the device, study protocol and statistical analysis plan throughout the seven-year ImpACT-24B study including a change in the pivotal study’s primary outcome target late in the study. FDA said it was concerned about “how the timing of the significant changes to the study protocol affects interpretation of the effectiveness study result, or the extent to which they were informed by information from interim analyses or unblinded treating investigators. A change in design and clinical use during a study may affect effectiveness and safety. FDA generally considers that the device used in a pivotal clinical study should be the final device, and the device should be used consistently throughout the trial unless it is found to raise safety concerns or present a danger to patients...”

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