French privately-held medical device company InHeart has received CE certification under the new European Medical Device Regulation (MDR) for an AI-based digital twin of the heart.

The firm’s software suite enables 3D visualisation and analysis of anatomical structures for image-guided cardiac ablations. With this certification, it will deliver fully automated segmentation of medical images with a software module based on machine-learning technology to European users. In addition, this certification should facilitate a swift pace of ongoing software enhancements.

Additional features of the product already available in the USA and now available in Europe with the CE Mark MDR certification include information (scar transmurality and left atrium wall thickness), visualisation and measurement tools, and an enhanced user experience.

“InHeart remains committed to delivering solutions that meet or exceed the highest quality and regulatory standards,” said Todor Jeliaskov, CEO of InHeart. “With this CE Mark MDR certification, we demonstrate our commitment to provide physicians with 3D cardiac models they can trust to help them determine the optimal treatment plan for each unique patient. I am proud of the InHeart team and their commitment to this level of excellence.”

The technology aims to address many of the challenges of conventional cardiac ablations with its proprietary segmentation algorithm that analyses preprocedural CT and/or MR images to create detailed, interactive 3D models of the heart. This information allows physicians to optimise treatment strategies for cardiac ablation procedures based on each patient’s cardiac anatomy and supports pre-procedural planning and seamless integration into all major electroanatomic mapping (EAM) systems.

Early clinical evaluations have shown a potential to reduce VT procedure times by 60% compared with the conventional approach, from five hours to less than two hours. Shorter procedures are typically associated with superior safety and patient experience. In addition, these evaluations have demonstrated the potential for image-guided ablations to reduce failure rate by 38% compared with the conventional approach.

The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health while supporting innovation.