Understanding the FDA’s New Quality Management System Regulation (QMSR) for Medical Devices
Learn how the FDA’s new Quality Management System Regulation (QMSR) impacts medical device manufacturers, suppliers, and hospital procurement teams.
Blog: Explore Industry News, Announcements, and Resources
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Navigating the FDA Clearance Timeline: Drivers, and Trends
For medical device manufacturers, securing FDA clearance is a milestone that marks the transition from innovation to real-world impact. Yet, over the past few years, that journey has become increasingly...
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FDA’s New Guidance on Reprocessing Single-Use Devices: What It Means for Healthcare Facilities
On June 3, 2025, the U.S. Food and Drug Administration (FDA) released updated guidance concerning the reprocessing of single-use medical devices (SUDs). The update clarifies and tightens expectations around how...
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Medical Device Approval and AI
FDA’s Struggling AI Tool Raises Concerns for Medical Device Approval As artificial intelligence (AI) continues to influence industries from transportation to finance, healthcare regulators have also begun integrating AI into...
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Impact of FDA Layoffs on Used and Refurbished Medical Equipment Industry
The recent workforce reductions at the Food and Drug Administration (FDA) have stirred concerns across the medical technology sector. While many are focused on how these layoffs might delay approvals...
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Bipartisan Health Tech Investment Act Aims to Enhance Patient Access to AI-Enabled Medical Devices
In a move hailed by healthcare innovators and providers alike, U.S. Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) introduced the Health Tech Investment Act (S. 1399). The bipartisan bill aims...
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Protecting Medical Devices During Severe Weather
Severe weather events—whether hurricanes, floods, snowstorms, or heatwaves—can cause devastating disruptions to healthcare systems. One of the most critical areas at risk during such emergencies is medical equipment. From diagnostic...
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Supply Chain Challenges and Industry Trends in Medical Equipment
The medical equipment industry is undergoing significant changes, driven by supply chain disruptions, evolving technologies, and shifting market demands. As healthcare providers and medical facilities strive to adapt, the ability...
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The Financial Impact of Idle and Out-of-Service Medical Equipment on Hospitals
Medical equipment is essential to hospital operations, yet many healthcare facilities are unaware of the staggering costs incurred when equipment sits idle or requires frequent repairs. Research indicates that as...
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The Growing Advantage of Refurbished Medical Equipment in a Challenging Market
The Growing Advantage of Refurbished Medical Equipment in a Challenging Market The healthcare industry is facing unprecedented challenges as supply chain disruptions and tariffs on imported goods drive up the...
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How Tariffs and FDA Cuts Are Reshaping the Medical Equipment Market
The healthcare industry is undergoing significant changes as new tariffs and regulatory shifts impact the availability and cost of medical equipment. Tariffs on imported materials, combined with staffing reductions at...
