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FDA approves Seno Medical's breast cancer diagnostic technology combining ultrasound and opto-acoustic technology

Press releases may be edited for formatting or style | January 20, 2021 Women's Health

Seno's Chief Medical Officer, A. Thomas Stavros, MD, FACR, FSBI, believes that Imagio® is establishing a better standard for how diagnostic modalities should be judged. "Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses. Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high ≥98% sensitivity. The data from the PMA study shows that OA/US successfully achieved improved specificity at a fixed sensitivity of 98%, the part of the ROC curve where clinical decisions about whether or not to biopsy a mass are actually made."


Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical's Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical's OA/US imaging technology and applications, visit www.SenoMedical.com.
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