inHEART has obtained CE certification for its inHEART MODELS software suite to facilitate 3D visualisation and analysis of anatomical structures for image-guided cardiac ablations.

The company leverages a new software module based on machine-learning technology to offer fully automated segmentation of medical images. The certification enables the company to provide the solution to customers in Europe.

The certification was provided under the new European Medical Device Regulation (MDR 2017/745). It will further accelerate ongoing software improvements.

The inHEART solution has been updated with additional features including new information on scar transmurality and left atrium wall thickness, enhanced visualisation and measurement tools as well as an improved user experience. These features are already available in the US.

inHEART president and CEO Todor Jeliaskov said: “inHEART remains committed to delivering solutions that meet or exceed the highest quality and regulatory standards.

“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.”

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The primary objective of the inHEART solution is to tackle the numerous obstacles encountered in traditional cardiac ablations.

The company’s segmentation algorithm examines preprocedural computerised tomography or magnetic resonance images to generate detailed, interactive 3D models of the heart. By utilising this data, medical practitioners can enhance treatment approaches for cardiac ablation procedures.

This information also facilitates pre-procedural planning and integration into electroanatomic mapping systems.