Optoacoustic Ultrasound Device for Assessing Breast Lesions Gets Premarket Approval

A diagnostic tool that uses noninvasive optoacoustic ultrasound (OA/US) technology to differentiate between benign and malignant breast lesions was granted premarket approval by the FDA, according to the system developer, Seno Medical.¹

Imagio provides real-time information on suspicious breast lesions and helps physicians characterize and determine which masses require more invasive diagnostic assessment. The system is indicated to evaluate both palpable and nonpalpable breast abnormalities presenting during clinical presentation or mammography in adults who are referred for diagnostic imaging and work-up.

“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,” A. Thomas Stavros, MD, FACR, FSBI, Seno’s chief medical officer, said in a statement. “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 [receiver operating characteristic] curve where clinical decisions about whether or not to biopsy a mass are actually made.”

False-positive diagnostic evaluations are attributable to about $2 billion in wasted health care spending on breast biopsy procedures.² The makers of Imagio assert that the diagnostic system may help mitigate some of this waste by providing clinicians with real-time information about breast masses and increasing confidence in decision making.

The system technology uses OA/US, which combines laser optics and grayscale ultrasound, to provide functional and anatomical breast imaging. The optoacoustic component provides a “blood map” of the breast mass that is coupled with traditional anatomical imaging from the ultrasound. Its unique ability to assess angiogenesis and deoxygenation, 2 key characteristics of cancerous lesions, offers radiologists an opportunity to more accurately identify malignancy without the patient needing additional radiographs or contrast agents.

Along with the system, the SenoGram artificial intelligence support tool will aid physicians to interpret the images and provide training and certification to support transition from traditional imaging to OA/US.

“We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the [United States] with this FDA approval,” Tom Umbrel, Seno’s chief executive officer, said in a press release. “Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagio to market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision-making support that our novel OA/US imaging provides.”

PMA is a is the process by which the FDA reviews the safety and value of Class III medical devices—which are those that sustain or support human life, are instrumental in preventing human health impairment, or present a potentially significant risk of harm or morbidity—and is the most stringent type of device marketing application required.

References:

1. FDA approves Seno Medical’s ground-breaking breast cancer diagnostic technology. News release. January 19, 2021. January 20, 2021. https://bit.ly/2XVor6f

2. Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoecon Outcomes Res. 2018;10:157-167. doi: 10.2147/CEOR.S150260