January 19, 2021 – The Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology that helps physicians better differentiate between benign and malignant breast lesions. The company’s Imagio® Breast Imaging System uses non-invasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions in real time, helping providers characterize and differentiate masses that may – or may not – require more invasive diagnostic evaluation.
Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.1 Seno’s Imagio® technology could mitigate that by giving providers additional real-time information regarding suspicious breast masses and increased confidence to make a better decision regarding the need for diagnostic breast biopsies.
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