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Analogic Corporation Receives 510(k) Clearance from the US FDA for the SonixGPS® Nerve Block Needle Kit

Analogic Corporation, enabling the world's medical imaging and aviation security technology, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SonixGPS® Nerve Block Needle Kit.

The nerve block needles are used with Analogic's SonixGPS ultrasound technology, which is designed for guidance procedures such as nerve blocks for pain management and surgery.

Analogic will highlight this new 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 (Booth 100). The convention takes place March 29–April 2 in Las Vegas, Nevada.

"As ultrasound is used in more areas of patient care, Analogic is providing solutions that are easier to use, while successfully meeting today's procedure guidance challenges," said Lars Shaw, vice president of global marketing for Analogic. "As an example, ultrasound technology is often used by physicians to help guide complex needle procedures because it provides useful visualization 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 visualize 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."

The SonixGPS ultrasound guidance system uses multiple position sensors, including one embedded in the transducer, to provide unique ultrasound guidance for complex procedures, potentially reducing the learning curve for such procedures including nerve blocks, vascular access, core biopsies and fine needle aspirations. Using SonixGPS, physicians can insert the needle from any direction including in plane with the transducer, or out of plane. As a result, trajectory may be planned before inserting the needle to reduce unnecessary tissue manipulation, while maintaining patient comfort. 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.

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

Analogic's SonixTouch research systems may be configured for pre-clinical and clinical research using the same imaging platform. Featuring high-frequency imaging and a complete pre-clinical solution, the SonixTouch systems are compact, portable and customizable 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 open architecture and software development toolkits make it easy to develop unique user interfaces for new and proprietary medical devices that incorporate ultrasound imaging for groundbreaking applications.

The SonixGPS is available on the SonixTouch and SonixTablet™ ultrasound systems, which are equipped with a customizable touch screen interface. Click here to watch a video featuring Brian Pollard, M.D., who discusses how SonixGPS technology can assist in improving patient outcomes and optimize safety.

The SonixTouch Research system offers clinicians the ability to acquire large cine loops of clinical data ranging from raw radio frequency (RF) signal in B-mode, color, pulsed wave, 3D/4D modes, or scan-converted data, to either eight bits or 16 bits of envelope data. To learn more, watch assistant professors Michael C. Kolios, Ph.D., and Jahan Tavakkoli, Ph.D., from Ryerson University, discuss their research initiatives using the SonixTouch system:

During the AIUM Annual Convention, Kris Dickie, director of engineering and managing director for Analogic Ultrasound, will present "Research Interface Design for Clinical Ultrasound" in the Neapolitan Ballroom I/II at 9:45 am on April 2.


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