Press Release
April 30th, 2025
LARALAB’s Platform Receives FDA 510(k) Clearance
The first fully automated AI platform for Structural Heart CT analysis now cleared in the U.S
MUNICH, GERMANY, April 30th, 2025 / LARALAB GmbH, a leader in AI-powered imaging for interventional cardiology, today announced that its platform has received FDA 510(k) clearance. This milestone makes the platform the first and only fully automated AI platform for comprehensive CT analysis across all key areas of Structural Heart – including the Mitral, Tricuspid, and Aortic Valves, as well as Cardiac Chambers.
Already CE marked under the MDR, the platform is now cleared for clinical use in both the U.S. and Europe.
A New Standard in AI-Driven Cardiac Imaging — validated through years of clinical collaboration
Built entirely on LARALAB’s proprietary deep learning technology, the platform enables high-precision anatomical assessment directly from standard CT data. It supports the clinical decision-making and procedural planning for transcatheter therapies such as TAVR, TMVR and TTVR.
It is the result of years of collaboration with top European heart centers, validated in multi-center studies, and used in clinical trials and research programs globally. With cloud-native deployment, it offers a secure and scalable solution for hospital systems, research organizations, and device companies alike.
About LARALAB
Founded in 2018 and based in Munich, LARALAB GmbH is dedicated to advancing interventional cardiology through AI and cloud technology. The company provides fully automated, regulatory-cleared solutions for transcatheter treatment planning in Mitral, Tricuspid, and Aortic Valve disease. For more information, visit contact us at contact@laralab.com.