Seno Medical’s Advanced Imagio® Imaging System Receives EU CE Mark Certification for Enhanced Breast Diagnostics

Seno Medical Achieves European CE Mark for New Imaging System

Seno Medical Instruments, based in San Antonio, Texas, has achieved a significant milestone by obtaining the CE Mark certification for its next-generation Imagio® Imaging System, Model 9100. This certification, governed by the European Union's Medical Device Regulation (MDR), confirms that the device meets the rigorous safety, performance, and quality standards necessary for medical devices sold in Europe.

The Imagio® System represents a leap forward in breast imaging technology. By utilizing a blend of opto-acoustic imaging, ultrasound, and artificial intelligence (AI), specifically the SenoGram® technology, the system is designed to assist healthcare professionals in distinguishing between benign and malignant breast lesions. This innovative approach not only improves diagnostic accuracy but also streamlines the evaluation process for a range of breast abnormalities.

Tom Umbel, CEO of Seno Medical, expressed excitement regarding the certification, highlighting the challenges posed by the EU MDR certification process. He stated, "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. 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 design of the Imagio® Imaging System incorporates state-of-the-art technology that merges functional, anatomic, and morphologic information. By utilizing light, sound waves, and proprietary AI, it offers a diagnostic imaging modality that enhances clinicians' confidence in their assessments. Unlike traditional imaging techniques such as mammography, the Imagio® system is non-invasive and does not expose patients to ionizing radiation or require the use of contrast agents. Additionally, patients experience no need for breast compression, which is often a source of discomfort during traditional imaging.

A standout feature of Imagio® is its capability to provide real-time imaging and same-day results. This facility is particularly beneficial in improving workflow efficiency within healthcare settings, thereby alleviating stress and anxiety for patients awaiting diagnostic results. The system is engineered for use by qualified healthcare providers who are tasked with evaluating both palpable and non-palpable breast abnormalities, enhancing patient care through quick and informed decision-making.

The recognition of the Imagio® system is not entirely new; Seno Medical first received its CE certification under the Medical Device Directive (MDD) in 2014. However, with the Model 9100 version, the company aims to optimize its market presence while ensuring compliance with contemporary regulatory demands and advancing medical imaging technology.

Founded with a commitment to enhancing cancer detection, Seno Medical's innovative opto-acoustic imaging technology offers a significant advantage over existing imaging modalities. Since its FDA approval in January 2021, followed by supplemental approval in June 2022, the Imagio® Imaging System has been making waves in the healthcare sector, thanks to its cutting-edge integration of light, sound, and AI technologies.

For more information about Seno Medical's Imagio® imaging technology and its applications in patient diagnostics, interested parties can visit their website at www.SenoMedical.com. The company invites collaboration and partnerships that will further enhance the efficiency and effectiveness of cancer diagnostics worldwide.