FDA Panel Supports Approval Of Hologic’s C-View Software For 3D Digital Mammography
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement approval endorsed by FDA’s Radiological Devices panel Oct. 24 would enable creation of 3D and 2D images from a single scan, thereby reducing radiation exposure compared to the current process.
You may also be interested in...
New Products In Brief
Bausch & Lomb gets approval for first-of-a-kind intraocular lens. Roche HbA1c assay is first to be cleared to diagnose diabetes. More product launches and approvals from the past week.
Hologic’s 3-D Mammo: Reimbursement Timing Uncertain Following Approval
Hologic says it is impossible to predict how long it will take to secure reimbursement for its newly approved Selenia Dimensions three-dimensional digital mammography system.
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.