SonoSite Gets FDA OK for Advanced Needle Guidance Technology

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The U.S. Food and Drug Administration (FDA) has given 501(k) clearance to Fujifilm SonoSite Inc.’s latest needle guidance technology that combines ultrasound imaging with advanced magnetics to allow physicians more precise control in deep needle-based procedures.

The new AxoTrack™ Needle Guidance Technology has been in development for a decade, the company says, and the hope is that the more precise and easier-to-operate guidance system will make ultrasound-guided procedures considerably faster and safer for patients. According to an in vitro study published in the Annals of Emergency Medicine 99.3 percent of vascular access procedures were successful on the first pass and first stick when AxoTrack was used. In comparison, vascular access procedures using the standard freehand method for ultrasound-guided central venous access were successful on the first pass and first stick just 37.1% of the time.

“It is well recognized that ultrasound visualization improves the accuracy and safety of deep needle-based procedures,” said Kevin M. Goodwin, SonoSite’s president and CEO in a press release announcing the launch of the technology. “AxoTrack takes this to a new level by reducing the spatial coordination required when a needle tip is typically not seen. Now physicians can observe the ‘virtual needle’s’ movement on the screen so they can be more accurate and avoid observed critical structures such as the carotid artery or the lung pleura.”

He added that the technology could make these procedures more approachable for new users and improve outcomes in patients. Those with pre-existing conditions, like low-blood pressure, that increase the odds of complications might be especially likely to benefit from the new needle-guidance technology.
The company has made the new AxoTrack™ Needle Guidance Technology available on SonoSite M-Turbo® Ultrasound Systems sold in the United States. It is composed of a specially designed ultrasound transducer from SonoSite and a single-use sterile procedure kit from Soma Access Systems LLC.

“Physicians that have seen the technology are amazed, and we have a large SonoSite customer base that has been waiting for it” Goodwin added.