In short
US medtech company Soma Access Systems LLC has announced that it has received 510(k) clearance from the FDA for its AxoTrack sterile procedure kit. The company’s brace of good news stories is completed with last week’s news that portable ultrasound specialist company Terason, itself received 510(k) clearance for the first ultrasound probe to be equipped with Soma’s patented AxoTrack virtual needle technology.
Background
According to a company press release, 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 visualisation 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).
Company comments
“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.
Availability
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. The company makes no mention of availability outside USA, so we’re assuming it’s not yet CE marked.
(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, PR Newswire
published: March 29, 2012 in: Approval/Clearance, Regulatory, Specialty, Techniques, USA