Evaluation of a Portable Ultrasound System for Peripheral Intravenous Access: Performance and Safety in a Clinical Setting.

Background: Ultrasound-guided vascular access has been increasingly used in clinical practice with studies supporting improved insertion success and reduced complications. To meet the needs of various vascular access applications, ultrasound systems have been evolving with specific features. This study evaluated the safety and performance of a recently developed portable ultrasound system with needle tracking technology for peripheral intravenous catheterization. Methods: The prospective observational clinical study was conducted at one US medical center between November 2025 and January 2026. Eligible participants requiring peripheral intravenous access underwent ultrasound-guided insertion for peripheral intravenous catheterization. Primary endpoints included successful visualization of target vasculature and successful intravenous access. Safety was assessed by the incidence of device-related adverse events. Descriptive statistics and exact binomial confidence intervals were calculated. Results: A total of 149 subjects were enrolled, including 17 pediatric (1-17 years) and 132 adult (≥18 years) patients. Ninety-six of these patients presented with at least one DIVA risk factor, including no visible veins, no palpable veins, a history of difficult IV access, IV drug use, or a BMI ≥ 30 kg/m Conclusion: The portable ultrasound system was associated with high first-attempt insertion success and high vascular visualization for peripheral intravenous access with no adverse events. The portable ultrasound system can be successfully used for bedside vascular access in a real-world environment.