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Seno Medical's Next-Gen Imagio® Imaging System Obtains EU MDR CE Mark
The certification allows Seno to market and sell the latest version of its opto-acoustic and AI-powered breast imaging system in the European Union.
Jan. 28, 2026 at 8:23am
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Seno Medical has received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, under the European Union's Medical Device Regulation (EU MDR). The CE Mark indicates the system meets stringent safety, performance, and quality standards required for sale in the EU and beyond. Seno's Imagio® combines light, sound, and artificial intelligence to provide clinicians with new diagnostic information to differentiate between benign and malignant breast lesions.
Why it matters
The EU MDR certification is a major milestone for Seno, allowing the company to expand the reach of its innovative breast imaging technology to healthcare providers and patients across Europe. Imagio® offers a non-invasive, radiation-free alternative to existing modalities like mammography and MRI, with the potential to improve diagnostic confidence and streamline care pathways.
The details
Seno's Imagio® Imaging System, Model 9100, utilizes opto-acoustic imaging, which combines light, sound, and AI-powered SenoGram® technology to generate high-resolution, high-contrast images that can help clinicians better characterize breast lesions. Unlike mammography, Imagio® does not require breast compression and is not limited by body habitus as MRI can be. The system is designed to provide real-time information and same-day results to improve workflow efficiency and reduce patient stress.
- Seno Medical received its first CE Mark under the previous Medical Devices Directive (MDD) in 2014.
- The company's next-generation Imagio® Imaging System, Model 9100, received the new EU MDR CE Mark certification on January 28, 2026.
The players
Seno Medical Instruments, Inc.
A San Antonio, Texas-based medical imaging company committed to improving cancer diagnostics through its opto-acoustic imaging technology.
Tom Umbel
The CEO of Seno Medical.
What they’re saying
“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.”
— Tom Umbel, CEO (PRNewswire)
“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.”
— Tom Umbel, CEO (PRNewswire)
What’s next
With the new EU MDR CE Mark certification, Seno Medical can now market and sell the latest version of its Imagio® Imaging System in the European Union and beyond.
The takeaway
Seno Medical's Imagio® Imaging System represents a significant advancement in breast cancer diagnostics, offering a non-invasive, radiation-free alternative to existing modalities. The EU MDR CE Mark certification is a major milestone that will allow the company to bring this innovative technology to healthcare providers and patients across Europe.
