TechniScan, Inc. is a medical device company engaged in the development and commercialization of an automated, repeatable ultrasound breast imaging and diagnostic system. Known as SVARA â¢, the system uses a process called Warm Bath Ultrasound (WBU â¢) to provide physicians with automated, 3D, ultrasound images of the physical structures within the breast. TechniScan's WBU⢠imaging device (SVARA â¢) is limited by U.S. law to investigational use unless, and until, cleared by the FDA. Designed to provide physicians with a repeatable, non-invasive imaging tool off unrivaled sensitivity and specificity for the early and accurate detection of cancer and abnormalities, this operator-independent, automated breast imaging system is a software-controlled, fixed room, ultrasound system designed to maximize patient comfort during the scanning process. It enables the operator to perform an automated whole breast examination while the patient lies prone on the systemâs examination table with the breast comfortably suspended in a warm water bath maintained near skin temperature. The ultrasound array is moved in a continuous scan that collects a complete series of successive 3-D images of the breast. The resulting images can be viewed on a DICOM review station. The quality of the images generated by the system is relatively independent of operator skill and experience (unlike conventional breast ultrasound). TechniScan does not use ionizing radiation and this technology does not require breast compression. The TechniScan system additionally records, stores and catalogs data from each scan of each patient to a centralized
