FDA launches READI-Home Innovation Challenge focused on reducing hospital readmissions
The FDA launches the READI-Home Innovation Challenge to support medical devices aimed at reducing hospital readmissions through home-based care solutions.
FDA expands TAP Pilot: increased scope and participation
FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.
MDCG 2025-9: Breakthrough Devices Guidance Brings New Opportunities for Innovative Manufacturers
Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.