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EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMD13, T-sore, and Z-sore) and to assess fracture risk through the integrated FRAX® software. The BMDgs Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD as provided by DXA at the same anatomical location (BMDnxA), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDris Index is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.

The subject device, EchoS, consists of two main parts: the equipment EchoS device with its own probe and the software EchoStudio. - The EchoS device consists of EchoS device together with its probe, - . The software EchoStudio: user interface and algorithmic calculation software provided in installation disc. The EchoS device is connected to the computer via the USB port, and it is controlled by the EchoStudio to send the transmitting parameters to the EchoS device and to acquire the ultrasound (US) signals from EchoS device in order to calculate the BMDus and the other diagnosis parameters. The EchoS System is a PC-based device that employs an ultrasound probe to collect ultrasound (RF) signals for echographic applications. During the measurement, the ultrasound convex probe, connected by a standard connector to the EchoS device, is applied directly to the skin in correspondence of the lumbar vertebrae or proximal femur, applying a thin layer of ultrasound gel between the probe surface and the skin to facilitate acoustic coupling. The ultrasound waves emitted by the probe are reflected by the bone, and then detected by the same probe. During the scan, the algorithm automatically detects the bone interfaces and calculates the region of interest (ROIs) for data analysis. The automatic data processing is performed through the following steps: a custom developed signal pre-processing chain performs filtering, amplification and A/D conversion operations on the RF signals that are then passed to the EchoStudio software. EchoStudio includes RF signal analysis and spectral comparison with reference models for the calculation of diagnostic parameters (BMDus, T-score, Z-score), and generation of the final medical report. The relevant scan depth, focus position, and visualization parameter settings can be adjusted and set by the interface of the software - EchoStudio. EchoStudio software provides BMDus (in g/cm²), T-score and Z-score. It also estimates the 10-year osteoporotic fracture risk calculated with the original FRAX® algorithm that is integrated in the device.