Published 22 Mar 2023 Awarded EU MDR Certification for Its AI solutions


Back is proud to announce a significant milestone in our journey to transform radiological practices through artificial intelligence. Our AI-driven medical imaging software has achieved the CE Class IIb certification under the European Union Medical Device Regulation (EU-MDR). This notable certification highlights our adherence to the highest standards of safety, performance, and quality in the European Union, extending our reach across 31 countries.
Our portfolio, now among the most comprehensive in the EU, employs AI to detect a range of abnormalities in various radiological modalities, including Chest X-rays, Chest CT, Head CT, and Musculoskeletal X-rays. This advanced AI software is designed to support radiologists in diverse healthcare environments, enhancing their ability to interpret scans accurately and efficiently.
Prashant Warier, our Co-founder and CEO, emphasizes the significance of this achievement: "Attaining the EU MDR certification is not only a reflection of our commitment to product excellence but also a reinforcement of our global presence as a reliable AI software provider. This milestone is a testament to the rigorous validation our products have undergone, marking their deployment in over 1000 sites worldwide across more than 75 countries. The certification paves the way for expanding our influence in the EU market, aiming to improve patient outcomes with our state-of-the-art imaging AI solutions."
The EU MDR certification process is known for its stringency and thoroughness, ensuring medical devices meet the highest standards of safety and efficacy. Our products have been validated in 71 countries, demonstrating our global commitment to quality.
In collaboration with Erasmus MC, we have launched the AI Innovation Centre for Medical Imaging, a groundbreaking initiative to evaluate and enhance the robustness and impact of our AI solutions on patient outcomes. Dr. Jacob J. Visser, a radiologist and chief medical information officer at Erasmus MC, outlines the center's objective to rigorously assess the performance of our AI solutions in diverse patient cohorts, thereby solidifying their role in clinical decision-making and specific disease workflows like lung cancer, ER, and stroke.
The MDR certification is a significant acknowledgment of the safety and efficacy of our AI software, affirming its compliance with EU medical device regulations. This assures healthcare professionals and patients alike of our software's extensive evaluation and reliability in the global market.

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