The X9 dialysis system has received U.S. Food and Drug Administration breakthrough device designation, private medical technology company X9 said on October 26, 2026. The company also completed a second clinical study of the investigational needle-insertion system in patients undergoing hemodialysis.

Key Takeaways

  • The designation is intended to expedite development and review; it is not FDA clearance or approval.
  • The ACCESS-2 study enrolled 10 patients and reported no device-related adverse events.
  • The investigational system is not available for commercial sale in the United States.

What the X9 dialysis system designation means

The designation covers the system’s proposed use in helping healthcare professionals identify validated vascular access sites and guide needle insertion for hemodialysis. The device combines ultrasound imaging with power-assisted needle insertion.

The FDA’s voluntary Breakthrough Devices Program is intended to expedite the development, assessment and review of qualifying devices. Designation does not guarantee future marketing authorization.

Second study tested needle placement

ACCESS-2 was a prospective, single-center feasibility and safety study involving 10 patients receiving hemodialysis through an arteriovenous fistula. It included multiple dialysis sessions using the investigational device to assist needle placement.

X9 said the study demonstrated successful needle placement followed by initiation of dialysis and met its primary safety objective. No serious device-related adverse events or other device-related adverse events were reported.

DaVita, which provides kidney care, is an investor in X9, according to DaVita chief strategy officer Steve Phillips.

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