Regulatory Roundup: Device Ban Supported; Obesity Device Panel; Eyelid Weights
This article was originally published in The Gray Sheet
Executive Summary
FDA neuro panel supports FDA’s proposed ban of electrical stimulation devices used for “aversive conditioning.” The agency has officially scheduled an advisory panel meeting to consider EnteroMedics’s PMA for the implantable Maestro Rechargeable System as a weight-loss tool in obese patients. More regulatory news.
You may also be interested in...
FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated
Tests that look for many markers at a time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.
‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role
During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry.
US Beauty And Wellness People News: L'Oréal's SkinCeuticals USA, Gaia Herbs, Flexpower
L'Oréal names leadership pair at SkinCeuticals USA; Bündchen models healthy lifestyle for Gaia; and NBA Star Antetokounmpo invests in lotions firm Flexpower.