AI-Enabled Reduction of Animal Use in Cardiovascular Translational Medicine: Regulatory and Technological Perspectives

We outline practical steps for establishing credibility, including transparent data documentation, independent testing, and identifying where models can be reliably applied, and identify remaining challenges in data standardization and regulatory readiness. With ongoing alignment between regulators, standards bodies, and product developers, these alternative approaches could significantly reduce reliance on animal testing in cardiovascular research while maintaining or improving the quality of evidence.