X9 wins a Breakthrough designation for power-assisted dialysis cannulation

MedDevice Startups Staff · 1 day ago · 2 min read · Via GlobeNewswire

FDA granted X9 a Breakthrough Device designation for its Ultrasound System with Power-Assisted Needle Insertion in hemodialysis cannulation. The Wallingford, Connecticut company announced it on October 26. The system is investigational, with no clearance or approval behind it.

X9 also closed out ACCESS-2, a prospective single-center study in ten hemodialysis patients with arteriovenous fistulas, run across multiple dialysis sessions. Needle placement succeeded and dialysis started. The primary safety objective was met with no device-related adverse events reported.

The company came out of Joshua Makower's ExploraMed incubator and has raised nearly $13.7 million. DaVita Venture Group was the primary seed investor and led the Series B. DaVita chief strategy officer Steve Phillips said the dialysis provider is energized to support X9 as an investor.

Ten patients at one site is a feasibility read, not a pivotal one. Having the largest dialysis operator on the cap table is the harder thing to buy.

Questions & Answers

What did FDA grant X9 for its dialysis cannulation system?

FDA granted Breakthrough Device designation to the X9 Ultrasound System with Power-Assisted Needle Insertion for hemodialysis cannulation. X9 announced it on October 26, 2026. The system remains investigational and is not cleared or approved.

What were the results of the X9 ACCESS-2 study?

ACCESS-2 was a prospective single-center study in ten hemodialysis patients using arteriovenous fistulas across multiple sessions. Needle placement succeeded and dialysis was initiated, the primary safety objective was met, and no device-related adverse events were reported.

Who backs X9, Inc.?

X9 came out of Joshua Makower's ExploraMed incubator and is based in Wallingford, Connecticut. DaVita Venture Group was the primary investor in its seed round and led its Series B, and the company has raised nearly $13.7 million to date.

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