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Seno Medical's Next-Generation Imagio® Imaging System Achieves Prestigious CE Mark Certification

In a significant milestone for medical technology, Seno Medical Instruments has proudly announced the receipt of the CE Mark certification for its next-generation imaging system, Imagio® model 9100. This certification, essential for commercial sale within the European Union, reflects Seno Medical's commitment to high safety and performance standards for its innovative medical device.

Understanding the CE Mark Certification

The CE Mark indicates compliance with the stringent safety and quality requirements laid out by the European Union Medical Device Regulation (EU MDR). This certification is mandatory for any medical device wishing to be marketed in the EU, demonstrating that it has undergone rigorous evaluation by recognized European Notified Bodies. Tom Umbel, CEO of Seno Medical, expressed his excitement about this achievement, stating, "The EU MDR certification is one of the most challenging regulatory processes, and achieving this milestone for our latest version of the Imagio® system is incredibly gratifying."

Revolutionary Features of Imagio®

The Imagio® imaging system employs a cutting-edge blend of optoacoustic technology, sound, and artificial intelligence through its proprietary SenoGram® system. This unique combination aids healthcare professionals in distinguishing between benign and malignant breast lesions, making it a vital tool in patient care.

Utilizing optoacoustic imaging, the Imagio® system combines functional, anatomical, and morphological information to provide detailed insights that were previously unavailable. With high-resolution and high-contrast image outputs, the technology allows for faster and more reliable diagnostics, enhancing clinicians' confidence in decision-making.

Advantages Over Traditional Methods

One of the most remarkable features of the Imagio® system is its non-invasive nature. Unlike traditional mammograms, it avoids ionizing radiation, contrast agents, and the discomfort associated with compression. The system is also more accessible, free from body habitus limitations that often limit MRI efficacy. This enables health providers to offer real-time information and same-day results to patients, thereby enhancing workflow efficiency and minimizing patient anxiety.

The system is designed for trained and qualified healthcare providers to assess both palpable and non-palpable breast anomalies. It's particularly beneficial for patients referred for diagnostic imaging following clinical presentations or other imaging processes, such as screening mammograms.

A Future-Focused Company

Founded with the mission to improve cancer diagnostic efficiency, Seno Medical has been breaking new ground in the field of medical imaging. The FDA approved the Imagio® system in January 2021, followed by additional approvals in June 2022. With a focus on utilizing the synergy of light, sound, and artificial intelligence, Seno Medical aims to deliver previously inaccessible insights to healthcare professionals.

As the medical community in Europe embraces the innovative capabilities offered by the Imagio® system, Seno Medical looks forward to collaborating with European professionals to advance diagnostic processes for better patient outcomes. For more information about the Imagio® technology and its applications, visit SenoMedical.com.

For media inquiries, contact:
Alex Hamlow, (210) 615-6501, [email protected].