MyCardium AI, a leading innovator in cardiovascular imaging technology, is delighted to announce that its revolutionary AI-driven post processing analysis software for CMR (1CMR Pro) has received FDA 510(K) clearance. This significant milestone enables clinical use of the software in the US.
The FDA's approval underscores the efficacy and safety of MyCardium AI's software in a clinical environment, enabling healthcare professionals to make faster and more precise diagnoses. The software has already demonstrated superhuman performance in a research environment, so bringing this to point of care has the ability to transform cardiology.