Optoacoustic breast imaging developer Seno Medical Instruments has finished the final phase of a pivotal study to evaluate its Imagio breast imaging system.
Seno's PIONEER study, officially titled A Pivotal Study of Imaging With Optoacoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound, enrolled more than 2,100 subjects at 16 U.S. institutions. The study was designed to demonstrate that Imagio can provide physicians with vital information needed to determine whether a suspicious breast mass is cancerous or not, helping to avoid negative biopsy procedures, Seno said. PIONEER compared the sensitivity and specificity of Imagio with grayscale ultrasound for breast lesions.
Pilot results from the study will be presented at the upcoming RSNA 2015 meeting in Chicago, and the study will be used as the basis for a premarket approval application (PMA) with the U.S. Food and Drug Administration (FDA), Seno said.
The company also noted that results from a separate European postmarketing and clinical follow-up study, called MAESTRO, or "Imaging With Optoacoustics to Downgrade BI-RADS Classification Relative to Other Diagnostic Methodologies," will be presented at this week's European Society of Breast Imaging (EUSOBI) annual scientific meeting in London. Five sites from the Netherlands are currently participating in that study.
