Technology | April 02, 2012

FDA Clears Axotrack Needle Visualization System

April 2, 2012 — Soma Access Systems LLC received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AxoTrack sterile procedure kit. Portable ultrasound maker Terason also recently received 510(k) clearance for the first ultrasound probe to be equipped with Soma’s patented AxoTrack virtual needle technology.

Together, the Terason Ultrasound System AxoTrack-equipped probe and AxoTrack sterile procedure kit comprise a system specifically designed to perform needle-guided procedures accurately and successfully. The system provides a clear path straight to the anatomic target and uninterrupted needle visualization throughout an entire procedure. When tested in vitro, the first attempt success rate for accurate needle placement using AxoTrack technology was 99.3 percent versus 37.1 percent with the standard freehand method. [1]

“This device has the potential to increase physician accuracy and set a new standard of care, significantly reducing morbidity and mortality. The AxoTrack system successfully combines life-saving precision with user-friendly functionality,” said Stephen F. Ridley, M.D., president and chief medical officer of Soma Access Systems.

AxoTrack will be available on Terason ultrasound systems by mid-summer 2012. Additional ultrasound manufacturers are expected to launch AxoTrack platforms in the near future. Introduced as ExactTrack during beta testing, the AxoTrack system is the first product in a comprehensive portfolio of solutions from Soma Access Systems LLC that will carry the AxoTrack brand.

For more information: www.terason.com, www.somaaccesssystems.com.

Reference:
[1] Ferre, R.M., et al. The Use of a Novel Device Improves Real-Time Ultrasound Guided IV Access. Supplement to Annals of Emergency Medicine. Sept. 2010;56(3):S74.

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