Purpose: Provide an overview of the current market of regulatory-cleared artificial intelligence (AI) software for radiology.
Methods and Materials: An overview of CE marked AI products for clinical radiology is maintained online (https://www.AIforRadiology.com). Vendors were asked to verify and complete the product information. This overviewallows for analysis of market trends. Characteristics of the market were based on the state of the database on the 1st ofMay 2021.
Results: In May 2021 there were 161 CE marked AI products on the market, an increase of 36% compared with one yearprior. The growth from 2019 to 2020 was 69% (from 70 to 118 products). The number of vendors offering AI products onlygrew with 13% from 61 in 2020 to 69 in 2021. The average number of products per company therefore increased from 1.9to 2.3. The time from company founding to the first product on the market is on average 4 years and 1 month. Mostprevalent are tools for neuro and chest imaging. With respect to modality, CT and MR covered 62% of all products. Half ofthe CE marked AI products (51%) have also been cleared by the FDA. To our knowledge, only four products were CEmarked under the new Medical Device Regulations. Subscription or licensing are the most popular pricing models. Themajority of products are offered with both the option of local and cloud-based installation.
Conclusions: The growth of AI products new to the market is slowing down. This effect is even stronger for vendors.Existing vendors have been expanding their portfolios.
Clinical Relevance/Application: The market of AI products for radiology is growing. Our research provides a transparentoverview of the available products and their evidence.