Breast cancer is the most frequent cancer among women and one of the leading causes of cancer-related mortality and early diagnosis is essential to reduce the risk of mortality. First diagnostic tool is clinical imaging (mainly Mammography and Ultrasound) but suspicious findings usually require a biopsy to confirm the diagnosis; 2% of women who undergo a screening mammogram will require some type of breast biopsy (1,3 million women each year in Europe).Breast biopsy is an image-guided procedure that can use different imaging technologies. Apart from US-guided biopsy, which is a manual procedure with limited indications, all current solutions are based on discrete scans of static images taken at different steps during the procedure. This guidance method makes current biopsy techniques to be long procedures with limited accuracy.MAMMOCARE project will develop a PEM (Positron Emission Mammography)-guided breast biopsy system allowing real-time 3D visualization of the lesion and real-time guidance with continuous monitoring of both, lesion position and needle motion. The system will also allow for preoperative planning of the optimal needle path. Exclusive PEM technology used, having the highest sensitivity and spatial resolution in the market, will allow the detection of small lesions difficult to find with conventional morphological imaging technologies, contributing to earlier diagnosis.Real-time monitoring and control of biopsy procedure, together with the high precision mechanics of the biopsy positioning module will assure an accurate sampling of the target lesion as well as shortening the procedure with regard to current techniques.Thus, the consortium will offer an integral diagnosis system based on PEM Imaging, including a biopsy module compatible with this kind of imaging technology.The consortium integrates 3 SMEs with experience in PEM imaging technology, Mechatronics applied to medical devices and Software Development. Two of the partners will become providers of their developed technologies of the third partner which will integrate the whole MAMMOCARE parts and commercialise the final product. SMEs will increase their portfolio as well as their revenues, while opening new doors to other markets thanks to the knowledge acquired.R&D activities will be carried out by CSIC, IBV and HERI, increasing their expertise and knowledge, reinforcing new research lines and future projects. Clinical feasibility of the system will be assessed through a clinical validation study at the facilities of NKI, collaborating end-user, therefore demonstrating the MAMMOCARE contribution to defeat women breast cancer.