Seno Medical's Next-Generation Imagio Imaging System Receives EU MDR CE Mark Certification

Seno Medical's Imagio® Imaging System Achieves EU MDR CE Mark Certification

Seno Medical Instruments, based in San Antonio, Texas, has officially announced the receipt of CE Mark certification for its cutting-edge next-generation Imagio® Imaging System, Model 9100. This significant milestone allows the company to market and sell the innovative imaging technology within the European Union. The CE Mark is a symbol indicating that the product meets strict safety, performance, and quality standards set by recognized certification bodies in Europe.

Tom Umbel, the CEO of Seno Medical, commented on this achievement: "The EU MDR certification represents one of the most challenging regulatory pathways, and we are thrilled to have reached this crucial milestone for our latest version of the Imagio® system. Imagio® offers a revolutionary leap forward in patient care, and we are excited to partner with our European colleagues to enhance diagnostic processes for providers and patients alike."

The Imagio® Imaging System assists healthcare providers in distinguishing between benign and malignant breast lesions through a novel combination of technologies including artificial intelligence (SenoGram®), ultrasound, and opto-acoustic imaging. This advanced methodology facilitates the characterization of masses, determining whether they necessitate invasive diagnostic assessments.

Having obtained its first CE Mark under the medical device directives (MDD) in 2014, Seno Medical's updated Imagio® system boasts an optimized design integrating state-of-the-art opto-acoustic imaging technology with native AI capabilities for clinical decision support. The technology merges light, sound, and AI, delivering new insights previously unavailable to clinicians.

Opto-acoustic imaging stands out as a novel approach in medical imaging, providing functional, anatomical, and morphological information through the synergistic use of light and sound. The proprietary AI technology (SenoGram®) ensures that clinicians receive high-resolution, contrast-enhanced images, alongside decision-making support, ultimately enhancing diagnostic confidence.

One of the notable features of the Imagio® system is its non-invasive nature, absence of ionizing radiation, and lack of need for contrast agents, differentiating it from traditional mammography. It doesn't require breast compression and does not impose limitations based on body habitus like MRI does. Additionally, Imagio® offers real-time information to clinicians, allowing for results to be delivered on the same day, significantly improving workflow efficiency and reducing patient anxiety.

The system is intended for use by qualified healthcare providers to assess palpable or non-palpable breast abnormalities in adult patients, referred for diagnostic imaging following clinical evaluation or other imaging tests, such as screening mammograms.

Seno Medical Instruments actively focuses on enhancing the efficiency and reducing complexities surrounding cancer diagnostics through its opto-acoustic imaging. The Imagio® Imaging System represents a groundbreaking modality, integrating light, sound, and artificial intelligence to provide previously inaccessible information to clinicians. The system received FDA approval in January 2021, with a supplement in June 2022, resulting in markedly improved reliability of diagnostic outcomes, facilitating real-time evaluations and optimized treatment pathways. To explore more about the Imagio® imaging technology and its applications, visit www.SenoMedical.com.