Functional opto-acoustic (OA) imaging was fused with gray-scale ultrasound acquired using a specialized duplex handheld probe. Feasibility Study findings indicated the potential to more accurately characterize breast masses for cancer than conventional diagnostic ultrasound (CDU). The Feasibility Study included OA imagery of 74 breast masses that were collected using the investigational Imagio® breast imaging system. Superior specificity and equal sensitivity to CDU was demonstrated, suggesting that OA fusion imaging may potentially obviate the need for negative biopsies without missing cancers in a certain percentage of breast masses. Preliminary results from a 100 subject Pilot Study are also discussed. A larger Pivotal Study (n=2,097 subjects) is underway to confirm the Feasibility Study and Pilot Study findings.