New Products In Brief
This article was originally published in The Gray Sheet
Executive Summary
J&J wins ceramic-on-metal hip approval
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Tria Beauty postpones IPO. Agendia raises $65 million for cancer tests. Kona Medical gets $30 million for hypertension device development. More financings.
FDA Orders Post-Market Studies On Metal-On-Metal Hips
FDA has ordered 21 current and former manufacturers of metal-on-metal total hip replacement systems to conduct post-market surveillance studies of their devices to assess metal toxicity risks.
J&J/DePuy's Ceramic-On-Metal Hip Is Approvable With Conditions - Panel
Johnson & Johnson/DePuy's CoMplete ceramic-on-metal acetabular hip system should be approved by FDA, according to the agency's Orthopedic and Rehabilitation Devices Panel