We have developed a clinically compatible, real-time ultrasound needle tracking system (UNT) that can be appended to a clinical ultrasound system, superimposing a crosshair onto the ultrasound image at the needle tip position. The UNT was developed under the ISO 13485 Medical Devices quality standard for deployment in the clinic. During handheld ultrasound guidance, the location of the needle tip within the imaging plane is determined from the acoustic signals received by an embedded fibre-topic hydrophone. Assessment of tracking accuracy found that the mean distance between tracked and true positions was 0.7 ± 0.4 mm with a repeatability of 0.3 ± 0.2 mm.
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