Seno Medical Secures CE Mark Certification for Next-Generation Imagio® Imaging System

Seno Medical Instruments, Inc. has announced that its next-generation Imagio® Breast Imaging System, Model 9100, has received CE Mark certification under the European Union’s Medical Device Regulation (EU MDR). The certification marks a key milestone for the company, enabling the commercial launch of its latest imaging system across the European Union and other markets that recognize the CE Mark.

“EU MDR certification is one of the most challenging regulatory processes, and we are so pleased to have achieved this significant milestone for our most recent version of the Imagio® System,” said Tom Umbel, CEO of Seno Medical. “Imagio® delivers a revolutionary leap forward in patient care, and we are thrilled to be able to collaborate with our European colleagues to improve diagnostic processes for providers and patients.”

The Imagio® Model 9100 combines ultrasound, opto-acoustic imaging, and proprietary artificial intelligence (AI) software, known as SenoGram®, to help clinicians differentiate between benign and malignant breast lesions. The system provides functional and morphological insights through a non-invasive imaging process that does not use ionizing radiation, contrast agents, or breast compression.

Seno Medical’s proprietary opto-acoustic imaging technology captures high-resolution images using laser-induced sound waves, providing real-time data about tissue composition and vascular activity. The integration of SenoGram® offers native AI-based clinical decision support, designed to enhance diagnostic accuracy and confidence at the point of care.

The updated Imagio® 9100 represents a market-optimized advancement over the company’s earlier systems. Seno first received CE Mark certification under the previous Medical Device Directive (MDD) in 2014. This new certification under the stricter EU MDR reflects compliance with globally recognized standards for safety, performance, and quality.

The system is indicated for use by trained healthcare professionals in the diagnostic evaluation of palpable and non-palpable breast abnormalities in adult patients, including those referred following clinical examination or screening mammography.

According to the company, the Imagio® system supports real-time decision-making and can facilitate same-day results, potentially reducing patient anxiety and streamlining workflow for imaging centers and specialty clinics.

With CE Mark certification now in place, Seno Medical plans to begin working with healthcare providers and distributors in Europe to make the Imagio® 9100 system more widely available.