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The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities. The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination. The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.

NeoNavia® biopsy system is designed to obtain tissue samples from breast lesions or axillary lymph nodes for histological evaluation. The system is composed of a base unit, a driver and two different types of sterile single use probes. Each probe type (also referred to as needle) utilizes pulses with the intention to improve precision and control when inserting and positioning the biopsy needle in a suspicious lesion. NeoNavia® must be operated together with ultrasound imaging guidance.