Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
A round-up of regulatory news affecting the medical device industry.
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J&J’s Sedasys Sedation Device Heads To FDA Appeals Panel Dec. 14
FDA’s Medical Devices Dispute Resolution Panel will vote Dec. 14 on the merits of the agency’s 2010 decision to deny PMA approval for Ethicon Endo-Surgery’s Sedasys computer-assisted personalized sedation system.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.