Successful MDR Certification for AI Solution in Predicting Postoperative Complications – New Product Generation for Optimized Patient Safety

Berlin, October 2, 2024

x-cardiac, a leader in AI-based medical devices for the prediction of postoperative complications after cardiac surgery, is pleased to announce the successful MDR (Medical Device Regulation) certification of its new x-cardiac-platform. This certification introduces a completely new generation of products offering state-of-the-art technologies to optimize patient care and safety.

The x-cardiac-platform is an innovative tool in the field of digital biomarkers and is specifically designed to increase patient safety and treatment quality in critical situations. With the successful MDR certification, the platform fulfills the strictest European requirements for safety and performance and thus marks a significant milestone in medical technology.

The new product generation includes two innovative plug-ins: x-c-bleeding and x-c-renal-injury. These plug-ins offer unprecedented support in the detection and treatment of bleeding and kidney damage after major heart surgery.

“With the new product generation, we can offer completely new possibilities for predicting postoperative complications in everyday clinical practice, which we will now increasingly promote beyond Germany, Austria, and Switzerland, also with sales partners,” says Oliver Höppner, CEO of x-cardiac. “With the x-cardiac platform, we are offering users a powerful medical device that can make a lasting difference in patient care. We are looking forward to the upcoming EACTS Annual Summit 2024 (European Association for Cardio-Thoracic Surgery) from October 10-12 in Lisbon, where we plan to present our new product generation to the professional audience.”

Chief Medical Officer Prof. Dr. Alexander Meyer on the new product generation: “The x-cardiac-platform sets new standards in the clinical care of patients by performing local validation of the algorithms for each customer. This enables us to ensure that our solutions are optimally tailored to individual needs and circumstances. Optional fine tuning allows us to customize the models to deliver even more precise results.”