FDA Gives Seno Medical Approval for Opto-Acoustic Breast Imaging System

It could soon be easier for radiologists to make an in-the-moment decision about whether a breast lesion is malignant or benign.

On Jan. 19, the U.S. Food & Drug Administration (FDA) granted pre-market approval (PMA) to the Imagio® Breast Imaging System from Seno Medical Instruments, Inc. This system uses non-invasive opto-acoustic ultrasound (OA/US) to help providers determine in real-time if an identified mass will require more invasive diagnostic evaluation.

Courtesy: Seno Medical Instruments, Inc.

Currently, breast biopsies due to false positives account for more than $2 billion in healthcare costs each year. Imagio®, which comes paired with an artificial intelligence decision support tool (SenoGram®) that helps providers transition from ultrasound to OA/US, could help this number drop, company officials said, by giving radiologists the information they need to be more confident in their assessments of lesions.

“Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (more than 98 percent) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses,” said Seno’s chief medical officer A. Thomas Starvos, M.D., FACR, FSBI. “Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high more than 98 percent sensitivity.”

Results from the PMA study, he said, reveal that OA/US does reach improved specificity at fixed 98-percent sensitivity -- the area of the ROC curve where radiologists decide whether to biopsy.

To attain this level of performance, OA/US brings together laser optics and grayscale ultrasound for fused functional and anatomical breast imaging. Alongside anatomical images, according to company details, the technology provides a blood map of the breast masses and the surrounding area that can reveal the presence or absence of angiogenesis and deoxygenation – two cancer hallmarks. With this data, a radiologist can better make decisions about whether to expose a patient to more diagnostic imaging.

This system is intended for use by trained radiologists to identify palpable and non-palpable breast abnormalities in adults who have been referred for diagnostic imaging breast follow-up after a screening mammogram.

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