Key result
Only ~3% of FDA-cleared cardiology AI devices are backed by high-quality clinical trials.
Most FDA-approved AI devices in cardiology are cleared via the 510(k) pathway with limited high-quality clinical evidence, highlighting a need for stronger regulatory frameworks and improved trial design.
Background Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency. Methods FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardiology-specific applications. Devices were categorised using the descriptive, diagnostic, predictive and prescriptive framework. Regulatory pathways, AI technologies and validation data were critically assessed. Results Of 1016 FDA-approved AI/ML devices, 277 (27.3%) had cardiology applications, predominantly for imaging (65.3%) and diagnostics (64.3%). Predictive and prescriptive tools constituted only 5.4% and 0.7%, respectively. Most devices (97.1%) were cleared via the 510(k) pathway, with 58.0% at risk of predicate creep. Quality of clinical evidence was limited, with only 3.2% of devices supported by high-quality trials. The type of AI technology was often underreported (58.8%). Conclusion While AI/ML technologies are reshaping cardiology, regulatory challenges and reporting transparency impede their optimal use. Strengthened regulatory frameworks, improved trial design and robust post-market surveillance are essential to ensure safety, efficacy and equity in the deployment of AI tools in cardiology.
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Hussain et al. (2025) conducted a review in Cardiology (n=1,016). FDA-approved AI/ML devices was evaluated on Proportion of devices with cardiology applications, regulatory pathways, and clinical evidence quality. Among 1,016 FDA-approved AI/ML devices, 277 (27.3%) had cardiology applications, with 97.1% cleared via the 510(k) pathway and only 3.2% supported by high-quality clinical trials.
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