#USA #San Antonio #Seno Medical #Imagio System #CE Mark

Seno Medical Secures CE Mark for Next-Generation Imagio® Imaging System

Seno Medical has announced that it has achieved CE Mark certification for its advanced Imagio® Imaging System, Model 9100. This prestigious mark from the European Union (EU) signifies that the device meets the highest standards for safety, performance, and quality, essential for the marketing and sales of medical devices across European borders.

CEO Tom Umbel expressed enthusiasm for this significant regulatory success, noting the challenges associated with the EU Medical Device Regulation (MDR) process. He highlighted how the Imagio® system represents a revolutionary advancement in patient care, reinforcing Seno Medical's commitment to enhancing diagnostic accuracy and processes for healthcare providers and patients alike.

The Imagio® System leverages a groundbreaking combination of opto-acoustic technology, ultrasound, and artificial intelligence (AI), embodied in its proprietary tool, SenoGram®. This innovative system allows medical professionals to more effectively differentiate between benign and malignant breast lesions, reducing the need for invasive diagnostic evaluations. With its recent evolution, the system not only promises more precise assessments but also increases confidence in diagnosis, potentially transforming treatment pathways for patients.

What sets the Imagio® system apart is its non-invasive approach. Unlike traditional imaging methods, it avoids the use of ionizing radiation and contrast agents, and eliminates the necessity for breast compression often required in mammograms. The technology provides real-time diagnostic information, enabling healthcare providers to deliver results on the same day. This speed not only improves clinical workflows but also alleviates patient anxiety and stress, making the diagnostic experience significantly more comfortable.

Historically, Seno Medical received its first CE Mark under the old Medical Device Directive (MDD) in 2014, and the 9100 model represents an updated design optimized for market needs. The integration of state-of-the-art opto-acoustic imaging technology with robust AI decision support certainly marks a milestone achievement in the field of medical imaging.

The system is currently indicated for use among qualified healthcare practitioners to evaluate both palpable and non-palpable breast abnormalities. This includes cases where patients are referred for further imaging following initial examinations, such as screening mammography.

Seno Medical, headquartered in San Antonio, Texas, is steadfast in its mission to simplify and enhance cancer diagnostics through its cutting-edge modality of opto-acoustic imaging. After receiving U.S. FDA approval in January 2021 and an additional authorization in June 2022, the Imagio® Imaging System now stands at the forefront of medical technology, promising to provide clinicians with previously inaccessible data.

Ultimately, the launch of the CE Mark-approved Imagio® Imaging System is not just a regulatory win for Seno Medical; it signifies a potential shift in how breast conditions are diagnosed across Europe. As Seno continues to move forward in collaboration with healthcare facilities, the future looks promising for improved patient outcomes and innovations in diagnostic care. For additional information about Seno Medical and its unique imaging technologies, visit www.SenoMedical.com.