Berlin-based medical technology company, x-cardiac, has announced the successful certification of its new x-cardiac-platform under the Medical Device Regulation (MDR). This certification marks a major milestone for the company and introduces a new generation of products that utilize cutting-edge technologies to improve patient care and safety.
The x-cardiac-platform is a groundbreaking tool in the field of digital biomarkers and is specifically designed to enhance patient safety and treatment quality in critical situations. With the MDR certification, the platform meets the highest safety and performance standards set by European regulations.
The new product generation includes two innovative plug-ins: x-c-bleeding and x-c-renal-injury. These plug-ins provide unprecedented support in the detection and treatment of bleeding and kidney damage after major heart surgery.
CEO of x-cardiac, Oliver Höppner, expressed excitement about the potential impact of the new product generation. “With this release, we are able to offer new possibilities for predicting postoperative complications in everyday clinical practice, and we plan to expand our reach beyond Germany, Austria, and Switzerland with the help of sales partners,” he said. Höppner also mentioned the upcoming EACTS Annual Summit 2024 (European Association for Cardio-Thoracic Surgery) in Lisbon, where the company plans to showcase their new products to a professional audience.
Chief Medical Officer, Prof. Dr. Alexander Meyer, highlighted the unique capabilities of the x-cardiac-platform. “Our platform sets new standards in patient care by conducting local validation of algorithms for each customer. This ensures that our solutions are tailored to individual needs and circumstances, and optional fine tuning allows for even more precise results,” he explained.
For further information, please contact:
Oliver Höppner
x-cardiac GmbH
presse@xcardiac.com
www.xcardiac.com
This article was distributed by Pressat, a press release distribution service, on Wednesday 2 October, 2024.
