Seno Medical’s TRUST registry to assess the effectiveness of …


MedTech Perspectives | Wednesday 10 November 2021

CONFIDENCE evaluates the effectiveness of ultrasound imaging in the diagnosis of breast abnormalities.

FREMONT, California: Breast ultrasound is a kind of imaging test that a doctor may order to look for tumors or other abnormalities in the breast. Breast ultrasounds generate detailed images of the inside of your breast using high frequency sound waves. A breast ultrasound can help the doctor determine if patients have a breast mass. have a solid tumor or cyst filled with fluid. require additional testing to rule out breast cancer. Texas-based Seno Medical Instruments has developed the CONFIDENCE registry to assess the effectiveness of opto-acoustic / ultrasound (OA / US) imaging to diagnose breast abnormalities, including cancer, using their imaging system Revolutionary Imagio® breast enhancement. A dozen sites will participate in the international registry, which will enroll a total of more than 600 patients over the five-year duration of the study, which ends in 2024.

“We believe, like other hybrid imaging modalities such as PET / CT, that the sum of optoacoustics and ultrasound provides superior sensitivity and specificity to each of the imaging modalities taken. individually, ”says Shaan Schaeffer, vice president of clinical operations at Seno the registry.

The company’s OA / US technology merges functional and anatomical breast imaging using laser optics and grayscale ultrasound. Optoacoustic imaging creates a unique blood map in and around breast masses, while ultrasound images create a more classic anatomical view. Seno Medical has demonstrated that the Imagio® OA / US Breast Imaging System is a more effective tool for radiologists to confirm or rule out malignancy than traditional diagnostic imaging modalities without exposing patients to ionizing radiation (x-rays) or potentially harmful contrast agents. In addition to the new imaging capabilities of the Imagio® system, Seno includes an artificial intelligence (AI) decision support tool (the SenoGram®) to help physicians interpret the new images. This tool allows radiologists to transition from ultrasound to OA / US imaging in conjunction with training and certification.

The system is approved for use by trained and qualified healthcare professionals to assess palpable and non-palpable breast abnormalities in adult patients referred for diagnostic imaging breast examination due to clinical presentation or other diagnostic procedures. ‘imaging such as screening mammography.

Senos President and CEO Tom Umbel comments: “This registry study will help us justify the effectiveness of the Imagio® system in a real-world setting and the ability of OA / US to benefit physicians and patients in the hospital. whole world.

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