Devices

FDA Convening Panel on Virtual Reality Devices

FDA has announced a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented reality (AR) and virtual reality (VR) medical devices.

“From diagnostics to clinical decision making, to surgical support, and to directly treating patients, AR/VR devices are used across multiple medical specialties,” an agency notice says. “These devices have novel attributes and considerations for the end users that impact FDA’s evaluation of the device’s safety and effectiveness. The novel attributes of digital health visualization, tracking techniques, embedded software among other factors present unique challenges for pre- and postmarked evaluation.”

FDA says that panel recommendations will address factors FDA and industry should consider when evaluating the benefits and risks for such devices. The committee will also be tasked with considering specific challenges related to certain populations (e.g., pediatric or cognitively impaired) who may use the technology.

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