Esaote Receives FDA Clearance for Virtual Navigator Ultrasound Fusion Imaging

May 13, 2014 — Esaote North America received U.S. Food and Drug Administration (FDA) clearance to market and sell its Virtual Navigator fusion imaging technology for ultrasound to U.S. customers.

Virtual Navigator provides the ability to fuse real-time ultrasound images with magnetic resonance imaging (MR), computed tomography (CT), positron emission tomography (PET) or 3-D ultrasound. Particularly useful for liver and other abdominal interventions, Virtual Navigator can also be used for gynecologic, musculoskeletal, obstetric, urologic, peripheral vascular and transcranial radiologic exams.

In use throughout Europe since 2002, Virtual Navigator is designed for easy integration into daily clinical practice and is available in the United States with a fully realized and robust feature set, including:

• Fast Image Registration, using either single reference point or anatomical marker techniques
• Intelligent Positioning, which acts like a GPS system to track movement of the probe as it is guided to the clinical target
• Virtual Biopsy, which superimposes needle tracking on real-time images to help the operator during complex interventional procedures
• Motion Sensor Technology, which automatically compensates for patient movement as it maintains image registration

“Virtual Navigator makes interventional procedures easier and safer,” said Brian Murphy, Esaote’s vice president of ultrasound marketing and sales. “Available in basic, advanced and extended versions, Virtual Navigator is a configurable and upgradable solution that enables institutions to purchase the capabilities they need today and upgrade as needs change in the future.”

Currently cleared for use with Esaote’s MyLabTwice system, the Virtual Navigator software option is intended to support a clinical radiological ultrasound exam and follow a percutaneous procedure by providing additional information from a second imaging modality.

Virtual Navigator works with a wide selection of transducers.

For more information: www.esaoteusa.com