Texas-based Seno Medical Instruments has received premarket approval from The Center for Devices and Radiological Health in the U.S. for its diagnostic breast cancer imaging technology. The new technology helps physicians differentiate between malignant and benign breast lesions.
Seno Medical’s Imagio Breast Imaging Systems uses noninvasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions in real time. This helps providers characterize and differentiate masses that may or may not require more invasive diagnostic evaluation. The technology also combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The ultrasound provides a traditional anatomical image while the opto-acoustic images provide a unique blood map in and around breast masses.
Through the appearance or absence of angiogenesis or deoxygenation, two hallmark indicators of cancer, Seno Medical show that the Imagio OA/US Breast Imaging System will be effective in helping radiologists confirm or rule out malignancy, more so than through traditional diagnostic imaging modalities. The new technology does not expose patients to potentially harmful ionizing radiation or contrast agents.
SenoGram, an AI physician decision support tool is included to aid in interpreting the new images that help radiologists make the transition from ultrasound alone to OA/US Imaging. Training and certification is also necessary. The system is to be used by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients that have been referred for diagnostic imaging breast work-up following clinical presentation or other imaging exams like screening Mammography Device.
Tom Umbel, CEO of Seno Medical Instruments, said, “We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval. 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.”
This article was originally published in AXIS by Keri Stephens on January 19, 2021.
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At Atlantis Worldwide, we’re always excited to hear about new medical imaging modalities. While it will be a while before Seno Medical Instrument’s Imagio will be available in the secondary market, the technology promises to be an exciting addition to breast cancer diagnostics. In the meantime, if you are looking for new medical imaging equipment, it pays to explore the possibility of purchasing used or refurbished equipment, as it can provide the performance you want at a price that is kinder to your budget. Talk to Atlantis Worldwide before making a decision.
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About the author: Vikki Harmonay