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Terason and Soma Receive FDA Clearance for New Needle Visualization Technology


3/20/2012 8:08:04 AM

BURLINGTON, Mass.--(BUSINESS WIRE)--Terason, the leading manufacturer of high-performance portable ultrasound systems and Soma Access Systems LLC today announced that they have received 510(k) clearance from the FDA for a new transducer equipped with AxoTrack™ needle visualization technology. This innovative combination of traditional ultrasound imaging with virtual needle technology provides unprecedented real-time needle tracking for a variety of ultrasound-guided procedures. Terason is the first to offer Soma’s AxoTrack technology commercially on their ultrasound systems.

Terason, in an effort to continually provide their customers with solutions to further improve patient care, will begin offering the probe equipped with AxoTrack needle visualization technology commercially in the United States beginning mid-summer, 2012. Together with the AxoTrack I sterile procedure kit, produced and distributed by Soma, the complete system is specifically designed to perform needle-guided procedures accurately and successfully. In studies, the system has achieved a 99.3% first attempt success rate[1].

This game-changing technology from Soma enables physicians to precisely plot the needle’s trajectory and observe real-time progress as the needle travels through tissue to the intended target. Patient care is improved as doctors carry out procedures such as vascular access, biopsy, nerve block, cyst aspiration, arthrocentesis and paracentesis with increased accuracy and confidence.

“Terason’s award-winning ultrasound systems, coupled with AxoTrack revolutionary technology, combine to create another unique user experience for our customers,” says John Bridge, Chief Executive Officer at Terason. “We are proud to partner with Soma to pioneer the use of this technology and change the way many doctors approach needle guidance procedures.”

“AxoTrack represents a breakthrough in needle guidance and is designed to improve the safety of a broad range of needle-guided procedures,” says Stephen Ridley, MD, president and chief medical officer of Soma. “This device sets a new standard of care, significantly reducing morbidity and mortality.”

*AxoTrack is a registered tradename of Soma Access Systems LLC.

[1] 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.

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 864.240.7400.

About Terason

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.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50210101&lang=en

Contacts

Terason

Jeffrey Sirek, 781-270-4143

VP, Head of U.S. Business



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