Devices

FDA, NYU Partner on Stroke Rehab Review Tool

FDA and researchers from New York University are partnering to design a regulatory science tool (RST) based on data from biomarkers to improve the review processes for stroke rehabilitation devices and determine how best to use them. While there is a growing market of such devices, recommendations for how and when to use them are based mostly on subjective evaluation of the sensorimotor capacities of patients who use them, the researchers say. The team will design and validate a “robust recovery biomarker enabling a first-ever stroke rehabilitation RST based on exchanges between regions of the central and peripheral nervous systems,” the researchers say.

“There is currently no approved RST for assessing the efficacy of rehabilitative devices for post-stroke motor recovery,” explained NYU Tandon School of Engineering assistant professor S. Forokh Atashzar. “This unique collaboration will shed light on how neurological markers can demystify the complex patterns of neural communication, realizing an objective neurophysiological window to degradation in the interaction between anatomy, activation, and pathway in post-stroke patients.”

The project is supported by the U.S. National Science Foundation.

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