OBJECTIVES

To assess changes in peer-reviewed evidence on commercially available radiological artificial intelligence (AI) products from 2020 to 2023, as a follow-up to a 2020 review of 100 products.

MATERIALS AND METHODS

A literature review was conducted, covering January 2015 to March 2023, focusing on CE-certified radiological AI products listed on www.healthairegister.com . Papers were categorised using the hierarchical model of efficacy: technical/diagnostic accuracy (levels 1-2), clinical decision-making and patient outcomes (levels 3-5), or socio-economic impact (level 6). Study features such as design, vendor independence, and multicentre/multinational data usage were also examined.

RESULTS

By 2023, 173 CE-certified AI products from 90 vendors were identified, compared to 100 products in 2020. Products with peer-reviewed evidence increased from 36% to 66%, supported by 639 papers (up from 237). Diagnostic accuracy studies (level 2) remained predominant, though their share decreased from 65% to 57%. Studies addressing higher-efficacy levels (3-6) remained constant at 22% and 24%, with the number of products supported by such evidence increasing from 18% to 31%. Multicentre studies rose from 30% to 41% (p < 0.01). However, vendor-independent studies decreased (49% to 45%), as did multinational studies (15% to 11%) and prospective designs (19% to 16%), all with p > 0.05.

CONCLUSION

The increase in peer-reviewed evidence and higher levels of evidence per product indicate maturation in the radiological AI market. However, the continued focus on lower-efficacy studies and reductions in vendor independence, multinational data, and prospective designs highlight persistent challenges in establishing unbiased, real-world evidence.

KEY POINTS

Question Evaluating advancements in peer-reviewed evidence for CE-certified radiological AI products is crucial to understand their clinical adoption and impact. Findings CE-certified AI products with peer-reviewed evidence increased from 36% in 2020 to 66% in 2023, but the proportion of higher-level evidence papers (~24%) remained unchanged. Clinical relevance The study highlights increased validation of radiological AI products but underscores a continued lack of evidence on their clinical and socio-economic impact, which may limit these tools' safe and effective implementation into clinical workflows.