Health

FDA grants breakthrough status to ultrasound-guided dialysis needle device

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to an ultrasound-guided system designed to make hemodialysis needle insertion more consistent, X9, Inc. announced Monday. The designation is a development milestone for an investigational device — not a marketing approval.

The X9 Ultrasound System with Power-Assisted Needle Insertion is intended to help health care professionals identify validated vascular access sites and assist with guided needle insertion when cannulating a vascular access for hemodialysis, according to the company. Reliable vascular access is essential to dialysis treatment, yet needle insertion remains a demanding procedure, the company said.

“Reliable vascular access is essential to hemodialysis treatment, yet needle insertion remains a demanding procedure. Breakthrough Device Designation marks an important milestone for X9 as we work to address the significant unmet need in vascular access,” said Eb Bright, the company's chief executive.

X9 also announced the completion of ACCESS-2, its second clinical study evaluating the investigational technology in patients undergoing hemodialysis. The company said the study results, together with the designation, mark important progress toward advancing the system through continued clinical development.

DaVita, the kidney-care provider and an investor in X9, praised the milestone. “At DaVita, we see firsthand how even routine parts of the healthcare experience can create discomfort for patients. X9 has the potential to change that, not just in kidney care, but across healthcare,” said Steve Phillips, DaVita's chief strategy officer. The system will still need to complete clinical development and FDA review before it can be marketed.

Sources: X9, Inc. / GlobeNewswire (Oct 26, 2026), carried by Morningstar and FinancialContent.

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