A new modality for examining the breast, Elasticity Imaging, allows for the visualization and quantitative assessment of the mechanical properties of soft tissue. These mechanical properties, i.e. elastic (Young's) modulus and viscosity, are highly sensitive to tissue structural changes caused by various physiological and pathological processes.
Tactile Imaging, a branch of Elasticity Imaging, yields a tissue elasticity map, which is also called “stress imaging” or “mechanical imaging”. It quantitatively evaluates mechanical and structural properties of breast tissue. When breast tissue is altered by tumor growth, Tactile Imaging provides a reproducible quantitative characterization of the lesion as compared with background breast tissue. Using a tactile sensor array, Tactile Imaging translates the shape, size and hardness (elasticity) of a breast lesion into quantitative objective data and a permanent digital image useable by clinicians.
SureTouch is based on Tactile Imaging technology. It uses pressure sensors to obtain tactile input used in conjunction with processing algorithms to identify and characterize masses in breast tissue. It consists of a wand with a tactile sensor array connected to a touch screen display which processes and visualizes results. SureTouch has De Novo clearance from the Food and Drug Administration (FDA) as a visual mapping system for documentation of CBE findings. Its proprietary sensor array technology and processing algorithms are ideally suited for examining the breast as the technology is low-cost, portable, non-invasive, and radiation-free. The large elastic modulus difference between most lesion types and normal, healthy tissue, yields a fundamentally strong signal for detection, including larger breast sizes and dense breast tissue.
The high-resolution pressure sensor array, and advanced data processing methods, allows SureTouch to significantly exceed the detectable limit of lesion size and depth by conventional manual palpation techniques used during a CBE. SureTouch is capable of detecting significantly smaller lesions than a medical clinician.