The SureTouch Breast Exam is a cloud-based service enabled by proprietary tactile sensor technology. It is a painless, radiation-free digital breast exam comprised of a wireless sensor, a touch screen display, and the SureTouch network as illustrated in the image to the right.
The system is FDA-cleared (FDA #K010514) and is classified as a Class II medical device. The FDA recognizes SureTouch as a device for producing a surface map of the breast and an aid to document palpable breast lesions identified during a clinical breast exam. SureTouch utilizes tactile sensing technology, originally developed at Harvard University, and strain elastography pioneered by Artann, to accurately capture the sense of touch. SureTouch deciphers lesion information from raw tactile images by using advanced proprietary image algorithms as shown in the following image.
Breasts are examined quickly and comfortably, without compression or radiation. The patented, hand-held, SureTouch sensor glides easily over the entire breast and underarm area. Its 192 sensing elements capture and document the shape, location, size and hardness of breast lesions as demonstrated in the image below and the video at the top of the page.
Any breast lesions are displayed on the SureTouch console screen as two- and three-dimensional full-color images. Breasts are examined quickly (typically in 15 minutes or less) and accurately without compression or radiation.
A Bluetooth module provides communication between the sensor and display, allowing the display to provide real-time feedback to assist clinicians in the collection of data. The data is digitized and visualized as shown above. When the exam is finished, patient information and exam data are automatically uploaded to the SureTouch Network. Centralized servers receive and process the data, which can then be accessed by the physician. The patient receives a printed copy of the results at the time of the examination.