March 26, 2014 — Seno Medical Instruments Inc. presented two analyses of outcomes from a U.S. feasibility study of its investigational Imagio breast-imaging device at the annual meeting of the European Congress of Radiology 2014.
The first statistical analysis is of the feasibility study data (Abstract C-0926) and suggests that information from Imagio may have the potential to achieve clinically meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound. This will be verified in the ongoing U.S. pivotal study, which has already enrolled more than half of the 2,000 subject target. Imagio may be a useful tool to help physicians reduce the need for breast biopsy in patients with benign but suspicious appearing breast masses on conventional diagnostic breast ultrasound.
The second statistical analysis is of pre-defined histopathology findings relative to the specific features of benign and malignant lesions. This information was captured in the Imagio opto-acoustic images during the feasibility study. It suggests that Imagio may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman's diagnostic work-up, which will also be verified in the ongoing pivotal study.
Separate analysis of the feasibility data showed that OA findings could potentially correlate with molecular subtypes of breast cancer (Abstract C-1528). Imagio fuses an imaging technology based on light-in and sound-out called "opto-acoustics" with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn't expose patients to potentially harmful ionizing radiation (X-rays) or injectable contrast agents.
For more information: www.SenoMedical.com
December 08, 2025 
