Regulatory & Reimbursement
Breakthrough Bill Optimism, EU Reform Talk, Malaysia Joins MDSAP
In this week’s Pathways Picks: AdvaMed CEO Scott Whitaker is increasingly optimistic on legislative prospects for jumpstarting Medicare coverage of Breakthrough Devices; FDA officially rescinds the laboratory developed test rule, and refines its emergency policies for diagnostics; EU industry weighs in on short- and long-term MDR and IVDR reform; Malaysia joins the Medical Device Single Audit Program; China adds flexibility on device lab testing; and more news from Asia, Europe, and the US.
