Device Week – April 4, 2016
This article was originally published in The Gray Sheet
Executive Summary
In our latest European edition of the podcast, Clinica's Amanda Maxwell discusses where things stand with the move toward "scrutiny" mechanisms for high-risk devices; what the revised international ISO 13485 quality systems standard means for the EU; and regulatory questions around cranial stimulation devices with nonmedical claims.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
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.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.