Academic Journal
AI-Enabled Reduction of Animal Use in Cardiovascular Translational Medicine: Regulatory and Technological Perspectives.
| Title: | AI-Enabled Reduction of Animal Use in Cardiovascular Translational Medicine: Regulatory and Technological Perspectives. |
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| Authors: | Dinc, Rasit, Ardic, Nurittin |
| Source: | Life (2075-1729); Dec2025, Vol. 15 Issue 12, p1916, 23p |
| Subject Terms: | Artificial intelligence, Machine learning, Cardiovascular agents, Simulation methods & models, Animal experimentation, Safety standards |
| Company/Entity: | United States. Food & Drug Administration |
| Abstract: | Background: Animal studies remain fundamental to cardiovascular drug and device development, yet their ability to predict human responses is increasingly being questioned. The US Food and Drug Administration (FDA)'s April 2025 roadmap supports alternative testing approaches that strategically reduce animal use while increasing human relevance by combining laboratory methods, computer simulations, and artificial intelligence. This review examines AI-enabled alternative methodologies for cardiovascular safety assessment within established validation frameworks and regulatory acceptance programs. We describe machine learning approaches for predicting cardiac safety risks, automated analysis of human heart cells, and patient-specific computer simulations for evaluating medical devices. These tools can improve our understanding of biological mechanisms, focus limited animal studies on critical questions, and accelerate decision-making. Regulatory acceptance requires rigorous validation appropriate to each specific use and decision context. Conclusion: 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. [ABSTRACT FROM AUTHOR] |
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| Database: | Complementary Index |
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