The US Department of Justice filed an injunction to limit chloroprene emissions from Denka Performance Elastomer, a facility that makes device components as well as other neoprene products.

Industry trade groups applaud CMS’s proposal to increase transparency for prior authorization approvals but are asking for expedited timeframes to provide care.

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

Hogan Lovells partner Scott Loughlin spoke to Medtech Insight about data privacy for digital health companies in the wake of the FTC’s proposed $7.8m settlement with BetterHelp.

AdvaMed’s Medical Innovation Agenda for the 118^th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.

The FDA requested a 10% increase in budget authority for FY 2024, but diagnostic reform was left out of the proposal.