Terason receives FDA 510(k) clearance to use Soma's AxoTrack technology

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.

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."