Siemens Announces FDA Clearance of Virtual Touch Elastography Imaging

 

June 25, 2013

June 25, 2013 — Siemens Healthcare announced that the U.S. Food and Drug Administration (FDA) has cleared the Virtual Touch imaging ultrasound application, Siemens’ first commercially available implementation of Acoustic Radiation Force Impulse (ARFI) technology. Virtual Touch imaging is a revolutionary way of visualizing tissue stiffness, allowing clinicians to visualize pathology deeper into the body and more clearly than before. Using sound beams to gently compress tissue, Virtual Touch imaging displays a map, or elastogram, of relative tissue stiffness within the region of interest. This elastogram provides clinicians with more diverse clinical information and increases diagnostic confidence, improving clinical decision-making for more efficient patient care. Virtual Touch imaging is available on Siemens’ premium Acuson S2000 and ultra-premium Acuson S3000 ultrasound systems.

Virtual Touch imaging reduces dependence on user technique, improving interoperator reproducibility, an important aspect of clinical utility. Precisely focusing the ultrasound beam within the region of interest, Virtual Touch imaging maximizes sensitivity to create a more uniform elastogram. By comparison, existing manual compression techniques apply pressure merely at the skin surface, with uncontrollable stress applied in deeper tissues.

Virtual Touch imaging is cleared for use in abdominal, breast, thyroid, small parts and musculoskeletal exams. Since 2008, the technology has been commercially available in Europe and Asia, where it has proven to be a valuable tool in the detection, diagnosis, treatment and follow-up of cancer, chronic liver disease, and musculoskeletal degeneration and injury. Virtual Touch imaging features sensitivity to extremely small tissue displacements, which leads to enhanced border definition and improved depiction of lesion size. This sensitivity also helps enable clinicians to identify the stiffest portion of the tissue to enhance targeting of fine-needle aspiration (FNA) and biopsy sampling. 

“Siemens is proud to announce the FDA clearance of Virtual Touch imaging technology,” said Jeffrey Bundy, CEO, Siemens Healthcare ultrasound business unit. “Armed with this powerful visualization tool, clinicians in the United States can now more confidently assess lesion tissue stiffness, further enhancing their diagnostic confidence.”

“Virtual Touch imaging enables the user to avoid the limitations of compression elastography, compressing tissue without any user dependency to provide a higher-quality display of the lesion,” said Dirk-Andre Clevert, section head of the Interdisciplinary Ultrasound Center at Germany’s University Hospital Munich-Grosshadern, which uses ultrasound elastography imaging to examine many of the approximately 20,000 patients who are treated annually at the center.

For further information: www.siemens.com