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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...
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...
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...
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...
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...
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...
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...
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...
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...
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...