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CMS and FDA Launch RAPID Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices
The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced a new initiative on April 23, 2026, calle...

FDA Early Alert: Arrow Dialysis Catheter Kits Removed Over Sheath Failure Risk in Vascular Procedures
The U.S. Food and Drug Administration issued an early alert on April 24, 2026, regarding the removal of specific dialysis catheter kits manufactured b...

FDA’s QMSR Inspection Update Signals New Compliance Standards for U.S. Surgical Device Suppliers
A stronger non-recall story from the April 14–20 window is the FDA’s April 14, 2026 posting of materials from its town hall on Quality Management Syst...

FDA Class I Recall: Stryker TMJ Implant Correction Raises Skull Penetration Risk Concerns
WASHINGTON, April 20, 2026 — The U.S. Food and Drug Administration has classified Stryker’s correction involving certain patient-fitted temporomandibu...
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