Seno Medical’s Next-Generation Imagio Imaging System Receives EU MDR CE Mark Certification
Seno Medical received EU MDR CE Mark certification for its next-generation Imagio Imaging System, Model 9100, announced around January 26-28, 2026.
The certification allows marketing and sales of the system, featuring opto-acoustic imaging, ultrasound, and AI (SenoGram), in the European Union.
Imagio helps differentiate benign and malignant breast lesions without ionizing radiation, contrast agents, or compression, providing real-time results.
CEO Tom Umbel highlighted it as a significant milestone and revolutionary for patient care.
Previously FDA-approved in the US (2021, supplemental 2022); first CE Mark under MDD in 2014.