NICE Briefs: Oncotype Dx; Implantable Heart Failure Monitors; Endobronchial Valves; RF Ablation
This article was originally published in The Gray Sheet
Executive Summary
The U.K.’s National Institute for Health and Care Excellence (NICE) gives a thumbs-up to Genomic Health’s Oncotype DX test for breast cancer, and offers cautious support for implantable pulmonary artery pressure monitors in heart failure patients and endobronchial valves in emphysema patients. More NICE news.
You may also be interested in...
International News In Brief
Regulatory and funding developments from around the world.
CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.