Devices

Panel to Consider Neuronix’ NeuroAD for Alzheimer’s

The FDA Neurological Devices Panel will be asked to comment 3/21on clinical data submitted in a Neuronix PMA for NeuroAD that did not meet its primary efficacy point in a pivotal trial. The device is proposed as an adjunctive treatment for mild to moderate dementia of the Alzheimer’s type in a cohort of patients defined by a baseline screening score on a specific test.

A briefing document released by the agency in advance of the meeting says the NeuroAD provides transcranial magnetic stimulation delivered concurrently with cognitive training displayed on a computer touch screen. The two treatments are intended to target the same brain region to deliver a net therapeutic effect.

FDA says the mechanism of action of transcranial magnetic stimulation has not been established but Neuronix suggests that it may modulate synaptic activity, potentially enhancing the therapeutic effect of cognitive training.

The briefing document says Neuronix provided clinical data from a pivotal study and some supplemental investigations. Panel input is being sought on the device’s benefit/risk profile given the clinical data. FDA also wants input on the high level of uncertainty in the methodology of the trial and the conclusions drawn from the pivotal study post-hoc analyses and the post-hoc analyses using pooled clinical data. “Given the primary results of the pivotal study did not demonstrate device effectiveness, the post-hoc analyses form the basis for the company’s conclusion of device effectiveness in the intended population,” the device reviewers say. “FDA would appreciate panel input on issues regarding device safety, effectiveness, clinically meaningful benefit for an adjunctive Alzheimer’s disease therapy, and the overall benefit/risk ratio of the NeuroAD.”

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