FDA Clearance of Virtual Touch Elastography Imaging

Virtual Touch imaging is Siemens’ first commercially available implementation of Acoustic Radiation Force Impulse (ARFI) technology.

July 2, 2013
Manufacturing Group
Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

Siemens Healthcare officials announce that the Food and Drug Administration (FDA) has cleared the company’s 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 ever 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. Available on Siemens’ premium ACUSON S2000 and ultra-premium ACUSON S3000 ultrasound systems, Virtual Touch imaging demonstrates Siemens’ innovation and competitiveness – two components of the Healthcare Sector’s Agenda 2013 two-year global initiative.

Virtual Touch imaging reduces dependence on user technique, improving inter-operator 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 an extremely valuable tool in the detection, diagnosis, treatment and follow-up of cancer, chronic liver disease, and musculoskeletal degeneration and injury. Virtual Touch imaging features an excellent 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,” says 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.”

Redefining the use of ultrasound in the diagnosis, treatment, and therapy of diseases, Virtual Touch imaging is gaining international clinical acceptance, evolving into a new standard of care at an increasing number of institutions.

“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,” states Dirk-Andre Clevert, section head of the Interdisciplinary Ultrasound Center at Germany’s University Hospital Munich-Grosshadern. The hospital uses ultrasound elastography imaging to examine many of the approximately 20,000 patients who are treated annually at the center.