Seno Medical's CONFIDENCE Registry to Evaluate the Efficacy of Ultrasound Imaging to Diagnose Breast Abnormalities

MedTech Outlook | Wednesday, November 10, 2021

CONFIDENCE assesses the efficacy of ultrasound imaging in diagnosing breast abnormalities.

FREMONT, CA: Breast ultrasound is a sort of imaging examination that a physician may prescribe to check 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 assist the doctor in determining whether patients have a breast lump. have a solid tumor or a fluid-filled cyst. require extra testing to rule out breast cancer. Texas-based Seno Medical Instruments has come up with the CONFIDENCE registry to assess the efficacy of opto-acoustic/ultrasound (OA/US) imaging to diagnose breast abnormalities, including cancer, utilizing their ground-breaking Imagio® Breast Imaging System. Around twelve sites will participate in the international registry, which will enroll a total of over 600 patients throughout the study's five-year duration, which ends in 2024.

“We believe, much like other hybrid imaging modalities such as PET/CT, the sum of opto-acoustics and ultrasound together provide greater sensitivity and specificity than either of the imaging modalities individually,” states Shaan Schaeffer, VP of Clinical Operations at Seno on the registry.

The company's OA/US technology fuses functional and anatomical breast imaging through laser optics and grayscale ultrasound. Opto-acoustic imaging creates a unique blood map within 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 potentially harmful ionizing radiation (x-rays) or contrast agents. Along with the novel imaging capabilities of the Imagio® System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram®) to assist physicians in interpreting the new images. This tool enables 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 practitioners to assess palpable and non-palpable breast abnormalities in adult patients referred for diagnostic imaging breast work-up due to clinical presentation or other imaging procedures such as screening mammography.

Senos Chief Executive Officer, Tom Umbel, comments, “This registry study will help us substantiate the efficacy of the Imagio® System in a real-world setting and the ability for OA/US to benefit physicians and patients around the world.”