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Blog & Insights

Discover cutting-edge medical device innovations, manufacturing insights, and the latest MedTech trends  shaping the future of healthcare.

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MDUFA VI Reauthorization

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

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How Trump's 100% Semiconductor Tariffs Will Impact Medical Device Manufacturers

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 

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Medtronic's Hugo Surgical Robot Receives CE Mark for Advanced Vessel-Sealing Technology

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

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QMSR Implementation Guide

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

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FDA's Updated Cybersecurity Guidance

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 

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Quantum Sensing in Medical Imaging

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.

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US China Trade

How the New U.S. and China Tariff 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.

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