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.

Related Content

ASE Releases New Guide to Performing Comprehensive Transthoracic Echo Exams
News | Cardiovascular Ultrasound | January 21, 2019
January 21, 2019 – Medical experts have released “...
Triton College Launching Vascular Technology in Sonography Certificate Program
News | Ultrasound Imaging | January 09, 2019
Starting in spring 2019, Triton College’s Vascular Technology in Sonography Certificate Program will help working...
Breast Cancer Patients Have Less Heart Damage With Heart Drug and Trastuzumab
News | Cardio-oncology | January 03, 2019
Breast cancer patients who take a heart drug at the same time as trastuzumab have less heart damage, according to a...
Fujifilm SonoSite Showcases Point-of-care Ultrasound Portfolio At RSNA 2018
News | Ultrasound Imaging | December 20, 2018
Fujifilm SonoSite Inc. recently present its complete portfolio of point-of-care ultrasound (POCUS) systems at the 2018...
Opto-Acoustic Imaging Helps Differentiate Breast Cancer Molecular Subtypes
News | Ultrasound Women's Health | December 20, 2018
Seno Medical Instruments Inc. (Seno Medical) reported results of a study demonstrating that morphologic and functional...
Sponsored Content | Videos | Ultrasound Imaging | December 14, 2018
Based on Mindray’s Living Technology, the Resona 7 (Sapphire), ZS3 (Diamond) and TE7 (Crystal) new ultrasound upgrades...
Hitachi Medical Systems Europe Introduces Third-Generation Intelligent Vector Flow Mapping
News | Cardiovascular Ultrasound | December 07, 2018
Hitachi Medical Systems Europe introduced what it calls the next level of intelligent Vector Flow Mapping (iVFM) at...
GE Healthcare Unveils New Applications and Smart Devices Built on Edison Platform
Technology | Artificial Intelligence | December 05, 2018
GE Healthcare recently announced new applications and smart devices built on Edison – a platform that helps accelerate...
GE Healthcare Introduces Invenia ABUS 2.0
Technology | Ultrasound Women's Health | December 03, 2018
GE Healthcare recently launched the Invenia automated breast ultrasound (ABUS) 2.0 system in the United States. This...
Videos | Ultrasound Imaging | November 28, 2018
This is an example of the new Fetal HQ heart and vascular software from GE Healthcare for fetal ultrasound.