FDA approves Analogic’s SonixGPS nerve block needle kit

1 April 2014 (Last Updated April 1st, 2014 01:00)

Analogic has obtained US Food and Drug Administration’s (FDA) 510(k) approval for its SonixGPS nerve block needle kit, an anesthesia needle kit designed for use with SonixGPS ultrasound system.

Analogic has obtained US Food and Drug Administration's (FDA) 510(k) approval for its SonixGPS nerve block needle kit, an anesthesia needle kit designed for use with SonixGPS ultrasound system.

Analogic's SonixGPS ultrasound technology is designed for guidance procedures such as nerve blocks for pain management and surgery.

The SonixGPS is available on the SonixTouch and SonixTablet ultrasound systems that feature a customisable touchscreen interface.

Using multiple position sensors, including one embedded in the transducer, the SonixGPS ultrasound guidance system provides unique ultrasound guidance for complex procedures.

According to Analogic, the system potentially reduces the learning curve for such procedures that include nerve blocks, vascular access, core biopsies and fine needle aspirations.

"With the SonixGPS, physicians are able to more clearly visualise and predict the needle's trajectory during invasive procedures in real-time."

The SonixGPS system allows the insertion of needle from any direction, including in plane with the transducer, or out of plane. Consequently, the trajectory may be planned before inserting the needle to reduce unnecessary tissue manipulation, while maintaining patient comfort.

According to Analogic, SonixGPS provides a cost-effective solution that can operate at any depth or angle with consistent display of tip and needle position during the entire procedure.

Analogic's SonixTouch research systems feature high-frequency imaging and a complete pre-clinical solution. The SonixTouch may be configured for pre-clinical and clinical research using the same imaging platform.

The SonixTouch systems are compact, portable and customisable in order to include a range of new and upcoming technology such as contrast imaging, elastography, plane wave imaging, strain imaging and more.

In addition, Analogic Ultrasound has the flexibility to provide various OEM ultrasound platforms and OEM transducers to meet specific requirements.

The SonixTouch research system offers clinicians the ability to acquire large cine loops of clinical data ranging from raw radio frequency signal in B-mode, colour, pulsed wave, 3D/4D modes, or scan-converted data, to either eight bits or 16 bits of envelope data.

Analogic vice-president Lars Shaw said that as ultrasound is used in more areas of patient care, the company is designing solutions that are easier to use.

"As an example, ultrasound technology is often used by physicians to help guide complex needle procedures because it provides useful visualisation of subsurface anatomy, serving as a 'visual pathway' to the obstacles beneath the skin's surface.

"With the SonixGPS, physicians are able to more clearly visualise and predict the needle's trajectory during invasive procedures in real-time, resulting in the ability to select both the needle direction and angle that is safest and most comfortable for their patients.

"We are very excited to deliver our innovative SonixGPS needle guidance technology to anesthesiologists in the United States. Physicians in other parts of the world have been successfully using this technology to improve the speed and accuracy of difficult procedures," Shaw said.

Analogic will highlight the SonixGPS technology, as well as showcase its SonixTouch ultrasound research system, OEM transducers and its OEM ultrasound platform at the American Institute of Ultrasound in Medicine (AIUM) 2014 Annual Convention in Las Vegas, Nevada, 29 March through 2 April.