Articles from X9, Inc.

X9 Receives FDA Breakthrough Device Designation for Investigational Dialysis Cannulation System and Completes Second Clinical Study

ACCESS-2 study provides additional clinical experience with X9's investigational technology for vascular access in hemodialysis

By X9, Inc. · Via GlobeNewswire · October 26, 2026

X9, Inc. Announces Successful Completion of First-in-Human Feasibility Study for Ultrasound-Guided, Power-Assisted Needle Insertion Device in Hemodialysis Cannulation

WALLINGFORD, Conn., Nov. 12, 2025 (GLOBE NEWSWIRE) -- X9, Inc. today announced positive results from its first-in-human clinical feasibility study evaluating the X9 Ultrasound System with Power-Assisted Needle Insertion, the company’s innovative handheld device for ultrasound-guided, power-assisted needle insertion in arteriovenous fistula (AVF) cannulation for hemodialysis patients.

By X9, Inc. · Via GlobeNewswire · November 12, 2025