Articles
MDUFA VI Reauthorization: What Medical Device Companies Need to Know Now
August 15, 2025
The wheels are turning once again on the FDA's Medical Device User Fee Amendments (MDUFA) reauthorization process. On August 4, 2025, the FDA
How Trump's 100% Semiconductor Tariffs Will Impact Medical Device Manufacturers
August 8, 2025
The medical device industry faces a significant new challenge as President Donald Trump announced plans to impose 100% tariffs on semiconductor imports
Medtronic's Hugo Surgical Robot Receives CE Mark for Advanced Vessel-Sealing Technology
July 18, 2025
Medtronic just scored a big win in Europe with CE Mark approval for their LigaSure™ RAS vessel-sealing tech on the Hugo™ robotic surgery system
QMSR Implementation Guide: Practical Steps for Meeting the February 2026 Deadline
July 11, 2025
The medical device manufacturing landscape is undergoing a significant transformation with the FDA's finalization of the Quality
FDA's Updated Cybersecurity Guidance: What Medical Device Manufacturers Need to Know
July 3, 2025
The FDA released an updated cybersecurity guidance document on June 27, 2025, building upon its 2023 predecessor. This update addresses
Quantum Sensing in Medical Imaging: The Next Frontier for Boston's MedTech Innovators
June 3, 2025
Boston's MedTech leaders are pioneering quantum sensing to revolutionize medical imaging with earlier, more precise diagnostics at the molecular level.
How the New U.S. and China Tarrif Agreement is Reshaping MedTech Manufacturing
May 27, 2025
US-China tariff deal eases costs for MedTech makers, stabilizing supply chains and opening doors for strategic growth, reshoring, and renewed industry investment.