Seno Medical's New Imaging System Receives EU CE Mark Certification for Enhanced Medical Imaging

Seno Medical's Imagio® Imaging System Earns Esteemed CE Mark Certification

In a significant advancement for medical imaging, Seno Medical Instruments has announced that its next-generation imaging system, Imagio® Model 9100, has received the CE Mark certification under the European Union's Medical Device Regulation (MDR). This achievement not only underscores the system's compliance with stringent safety and performance standards but also paves the way for its commercial availability throughout the European market.

CEO Tom Umbel expressed enthusiasm about this milestone, noting, "Achieving the EU MDR certification is one of the most challenging regulatory processes. We are excited to reach this significant stage for our latest version of the Imagio® system, a groundbreaking advancement in patient care. We look forward to collaborating with our European colleagues to enhance diagnostic processes for healthcare providers and patients alike."

The Imagio® system is innovative in its approach to breast imaging, aiding healthcare professionals in distinguishing between benign and malignant lesions. This is accomplished through a unique combination of artificial intelligence, ultrasound technology, and opto-acoustic imaging. These capabilities allow for the characterization of masses that may or may not necessitate invasive diagnostic evaluation.

Seno Medical first acquired CE Mark certification in 2014 under the previous Medical Devices Directive (MDD). The newly updated Imagio® system features cutting-edge opto-acoustic imaging technology alongside native clinical decision support powered by artificial intelligence, known as SenoGram®. This synergy aids clinicians in detecting critical details that were previously inaccessible.

The Imagio® system’s technology integrates light and sound to generate high-resolution, high-contrast images augmented by AI decision support, thus enhancing diagnostic confidence. Notably, this non-invasive procedure avoids ionizing radiation, the use of contrast agents, and the discomfort commonly associated with mammography, while circumvents the limitations of body habitus seen in magnetic resonance imaging (MRI). This provides clinicians with real-time information, enabling same-day results and improving overall workflow efficiency in medical facilities.

Indications for the Imagio® system include its application by trained healthcare providers for investigating palpable and non-palpable breast abnormalities detected through clinical presentations or other imaging modalities, such as screening mammographies.

Seno Medical Instruments, headquartered in San Antonio, Texas, is committed to enhancing diagnostic efficiency and reducing complexity in cancer diagnostics. The Imagio® system, which received FDA approval in January 2021 and a supplemental approval in June 2022, consolidates the use of light, sound, and integrated AI to provide previously unavailable insights for clinicians. This results in significantly increased confidence in diagnostic outcomes, facilitating timely evaluations and streamlined patient care pathways.

For more information regarding the Imagio® imaging technology and its applications, visit www.SenoMedical.com. Inquiries can be directed to Alex Hamlow at (210) 615-6501 or via email at [email protected].