An innovative breast biopsy system guided by 3D real-time PEM (Positron Emission Mammography) imaging is being developed through an EU-funded project. The MAMMOCARE project, which kicked off in October 2013, promises to offer real-time needle guidance for higher accuracy and efficiency in tumour sampling. Breast cancer is by far the most frequent cancer among women, with an estimated 1.38 million new cancer cases diagnosed in 2008 - 23% of all cancers - and one of the leading causes of cancer-related mortality. Within the EU alone, a woman is diagnosed with breast cancer every 2.5 minutes and every 7.5 minutes a woman dies from the disease (3% of cancer deaths in European women is produced by breast cancer). It is estimated that about one in 12 women will develop the disease before the age of 75 years. Identifying breast cancer early is one of the most crucial factors in ensuring a patient's recovery. The first diagnostic tool is usually clinical imaging - mainly mammography and ultrasound - but suspicious findings usually require a biopsy to confirm the diagnosis. The biopsy involves taking a sample of cells or tissue for further examination. Some 2% of women who undergo a screening mammogram will require some type of breast biopsy (1.3 million women each year in Europe). It is important of course that the correct tissue is sampled. The more accurate the sample, the more accurate the diagnosis will be. This is why the EU is funding the development of a new image-guided procedure that uses PEM technology. Of all the current imaging technologies, PEM has the highest spatial resolution and sensitivity on the market. This will allow for the detection of the smallest lesions (1.5 to 2 mm) that may not be found out with other more conventional image technologies like RX, US or MRI. The new biopsy module will offer a higher accuracy than current image-guided biopsy systems, in order to enable the targeted sampling of small tumours. This will help medical staff to diagnose breast cancer at the earliest possible stages, improving patient prognosis and survival chances. And because the procedure duration will be shorter than current biopsy methods, MAMMOCARE promises to offer a cost-efficient alternative for breast cancer diagnosis as well. MAMMOCARE integrates three SMEs with experience in PEM imaging technology, mechatronics applied to medical devices and software development. Clinical feasibility will be assessed through a validation study in collaboration with the end-user.