January 14, 2026

Amplifi Vein Dilation System Gains FDA Breakthrough Device Designation

January 14, 2026—Amplifi Vascular, Inc., a developer of solutions for hemodialysis vascular access, announced it has been granted Breakthrough Device designation from the FDA and Category B assignment from the Centers for Medicare & Medicaid Services for the company’s Amplifi vein dilation system.

According to the company, the Amplifi vein dilation system is designed to enhance vein size and quality before creation of an arteriovenous fistula to enable more durable, reliable dialysis access and support the shift toward earlier, safer cannulation.

Amplifi Vascular’s comprehensive data set, which included first-in-human results from 19 patients, was a key factor in securing the designation, noted the company.

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January 14, 2026

Amplifi Vein Dilation System Gains FDA Breakthrough Device Designation

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