Digital Pathology Clearance Accelerates U.S. Market Entry
PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.
Device Approvals
TISSIUM’s De Novo FDA Authorization Signals Industry Shift
FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more