AxoTrack™ Needle Visualization System by Soma Receives FDA Clearance
3/28/2012 7:38:09 AM
GREENVILLE, S.C., March 27, 2012 /PRNewswire/ -- Soma Access Systems LLC has received 510(k) clearance from the FDA for its AxoTrack sterile procedure kit. This is coupled with last week's news that Terason, the leading producer of high performance portable ultrasound systems, received 510(k) clearance for the first ultrasound probe to be equipped with Soma's patented AxoTrack virtual needle technology.
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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 first time, every time. 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% versus 37.1% 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," says Stephen F. Ridley, MD, President and Chief Medical Officer of Soma Access Systems LLC.
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.
Headquartered near Boston, Massachusetts, Terason, a division of Teratech Corporation (www.terason.com), is a diagnostic ultrasound technology company setting new standards for image quality and ease of use. Using breakthrough system integration technologies, Terason helps improve patient care by enabling compact equipment to generate diagnostic images previously possible only using large, expensive machines. The leading manufacturer of high performance portable ultrasound systems, Terason was established by Dr. Alice Chiang in 1994 as a spin-off of Massachusetts Institute of Technology (MIT) Lincoln Laboratory. Since Terason introduced its first product in 2001, thousands of ultrasound systems have been shipped to clinicians and partners worldwide.
About Soma Access Systems
Soma Access Systems LLC was co-founded by Stephen F. Ridley, MD and M. Dexter Hagy in 2004 as a medical technology company that develops innovative devices to solve real-world medical problems while making healthcare safer, simpler and more cost effective. Visit www.SomaAccessSystems.com for more information about Soma Access Systems LLC and AxoTrack, or contact Caralyn Hagy 864.240.4700.
(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.
SOURCE Soma Access Systems LLC