The US Food and Drug Administration (FDA) has granted 510(k) approval to Soma Access Systems' AxoTrack sterile procedure kit.
Last week, Terason has received FDA 510(k) clearance for its ultrasound probe, when equipped with Soma’s patented AxoTrack virtual needle technology.
Together, Terason’s ultrasound system AxoTrack-equipped probe and AxoTrack sterile procedure kit comprise a system, which is designed to provide a clear path to the anatomic target and uninterrupted needle visualization throughout the procedure.
The system when tested in vitro, the success rate for needle placement using AxoTrack technology was 99.3% versus 37.1% with the standard freehand method.
Soma Access Systems president and chief medical officer Stephen Ridley said the device has the potential to increase physician accuracy and set a new standard of care, thus reducing morbidity and mortality.
Soma said AxoTrack will be available on Terason’s ultrasound systems by mid-Summer 2012.