Since 2023, US companies have bought 19 radiology AI products made in Europe. Lindstead traced the ultimate owner of all 410 CE-marked AI products in the Health AI Register on 4 October 2026.1 RadNet now owns 17 radiology products, more than any company except United Imaging of Shanghai. Across radiology, 210 of 309 products (68.0 percent) come from companies controlled outside the EU.
Summary
- US buyers took over 19 European radiology AI products since 2023. RadNet bought Gleamer of Paris and Kheiron of London, GE HealthCare bought icometrix of Leuven and Abbott bought LARALAB of Munich. They account for 19 of the 66 US-controlled radiology products (28.8 percent).
- Two in three radiology AI products come from outside the EU. 210 of 309 products are made by companies whose ultimate parent sits outside the EU. The United States leads with 66, ahead of China with 40. In pathology the picture flips: 64 of 101 products are EU-controlled.
- Evidence and certificates lag. 127 of 309 radiology products (41.1 percent) list no peer-reviewed study, and 30 of the 44 launched since 2024. 107 (34.6 percent) still sell on a certificate under the old Medical Device Directive, valid until 2028 at the latest.
Which European radiology AI did US companies buy?
Five European makers of CE-marked radiology AI came under US control between January 2023 and October 2026. The largest deal closed in March 2026, when RadNet of Los Angeles bought Gleamer, a Paris company known for its fracture detection tool BoneView.2 Gleamer had bought Pixyl of Grenoble a year earlier.4 GE HealthCare closed its purchase of icometrix, a Leuven maker of brain and lung imaging software, in November 2025.3
European makers of CE-marked radiology AI taken over by US companies since 2023
| Maker | Based in | US buyer | Products | Closed |
|---|---|---|---|---|
| Gleamer | Paris, FR | RadNet (DeepHealth) | 7 | March 2026 |
| icometrix | Leuven, BE | GE HealthCare | 7 | November 2025 |
| Pixyl | Grenoble, FR | RadNet, via Gleamer | 3 | March 2026¹ |
| Kheiron | London, UK | RadNet (DeepHealth) | 1 | October 2024 |
| LARALAB | Munich, DE | Abbott | 1 | October 2025 |
| Total | 19 |
Sources: Health AI Register, crawled 4 October 2026; buyer and target press releases and deal reports.2,3,4,5,6 ¹ Gleamer bought Pixyl in March 2025; Pixyl came under US control with Gleamer.
These 19 products are 28.8 percent of the 66 US-controlled radiology products in the register. RadNet, through its DeepHealth unit, also bought iCAD of New Hampshire in 2025. It now owns 17 products, and only United Imaging Intelligence of Shanghai owns more.
RadNet became the second-largest owner
Three of the seven largest owners of CE-marked radiology AI are American.
After its takeovers, RadNet owns 17 CE-marked radiology AI products, second only to United Imaging.
CE-marked radiology AI products by ultimate parent company, products
¹ Gleamer 7, DeepHealth 3, Pixyl 3, iCAD 3, Kheiron 1. ² icometrix 7, plus one product registered under GE HealthCare. Country of the ultimate parent's headquarters.
Source: Health AI Register, crawled 4 October 2026; Lindstead ownership research
View data table
| Category | Value | Group |
|---|---|---|
| United Imaging (CN) | 27 | 1 |
| RadNet (US)¹ | 17 | 1 |
| Aidoc (IL) | 16 | 1 |
| JLK (KR) | 10 | 1 |
| RapidAI (US) | 8 | 1 |
| GE HealthCare (US)² | 8 | 1 |
| Avicenna.AI (FR) | 8 | 2 |
Group 1: Controlled outside the EU. Group 2: EU-controlled. Unit: products.
Deals run in all directions. In total, 38 of the 309 radiology products (12.3 percent) changed owner in the period. European buyers took over 11 products, through Guerbet, Sectra, Philips and SyntheticMR. Buyers from Australia and South Korea took over 5 more.
All ownership changes of radiology AI makers in the register, 2023 to 2026
| Maker | New owner | Owner | Products |
|---|---|---|---|
| Gleamer | RadNet | 7 | |
| icometrix | GE HealthCare | 7 | |
| Intrasense | Guerbet | 4 | |
| Oxipit | Sectra | 4 | |
| iCAD | RadNet | 3 | |
| Pixyl | RadNet, via Gleamer | 3 | |
| Imbio | 4DMedical | 3 | |
| DiA Imaging Analysis | Philips | 2 | |
| Kheiron | RadNet | 1 | |
| LARALAB | Abbott | 1 | |
| Volpara | Lunit | 1 | |
| Combinostics | SyntheticMR | 1 | |
| contextflow | 4DMedical | 1 |
EU-controlledUS-controlledOther country
Source: Health AI Register, crawled 4 October 2026; deal sources per company in the CSV below. iCAD and Imbio were already based in the US before their takeover. contextflow: binding agreement of 1 June 2026, completion date not confirmed. Not included: the merger of Radiobotics (Copenhagen, 2 products) with Medimaps Group of Geneva, announced in March 2026 and not confirmed as closed.
Who controls the radiology AI that European hospitals can buy?
Lindstead traced each of the 121 radiology companies in the register to its ultimate parent and the country where that parent has its headquarters. 99 of the 309 products (32.0 percent) come from EU-controlled companies. US control covers 66 products, China 40 and South Korea 30.
The US is the largest single country
66 of 309 CE-marked radiology AI products have a US parent company.
US-controlled companies make 66 of the 309 CE-marked radiology AI products, more than any other country.
CE-marked radiology AI products by country of the ultimate parent, products
¹ Excludes Gleamer (7) and Pixyl (3), now US-owned. Before the takeovers France would have had 44. Nine largest countries shown. Denmark, Spain and Austria follow with 7 products each.
Source: Health AI Register, crawled 4 October 2026; Lindstead ownership research
View data table
| Category | Value | Group |
|---|---|---|
| United States | 66 | 1 |
| China | 40 | 1 |
| France¹ | 34 | 2 |
| South Korea | 30 | 1 |
| Israel | 19 | 1 |
| United Kingdom | 16 | 1 |
| Germany | 13 | 2 |
| Australia | 10 | 1 |
| Netherlands | 9 | 2 |
Group 1: Outside the EU. Group 2: EU member state. Unit: products.
The market is fragmented. 69 of the 121 radiology companies list a single product, and the five largest owners hold 78 of the 309 products (25.2 percent). Counting US-incorporated operating companies under a non-US parent as American, the US share rises from 21.4 to 24.3 percent.
Which products run in a US-controlled cloud?
Vendors state in the register how a product can be deployed: on hospital hardware, in a virtual machine, in the cloud or as a hybrid. 261 of the 309 radiology products give an answer. Most can run on premises: 229 of the 261 (87.7 percent). Cloud-only products are the exception, at 23 (8.8 percent).
For US-controlled vendors the picture shifts. 27 of their products are offered as a cloud service, and 15 of those 27 (55.6 percent) come from the European companies US buyers took over: icometrix 7, Gleamer 4, Pixyl 3 and Kheiron 1. Eight US-controlled products run only in the cloud, seven of them icometrix brain and lung tools.
That matters because of the US CLOUD Act. It lets US authorities order a provider under US jurisdiction to disclose data in its possession, custody or control, wherever the data is stored.7 A hospital that uses the cloud version of a US-controlled product sends scans to a company that answers to that law. The register does not say which cloud a vendor uses or where it hosts data, so a European vendor may also run on Amazon, Microsoft or Google infrastructure. Lindstead could not measure that. The guide to the CLOUD Act and AI data sets out what the law reaches.
How much published evidence backs these products?
Each product page in the register lists studies about the product, typed as peer-reviewed or not. 127 of the 309 radiology products (41.1 percent) list no peer-reviewed paper. That includes 108 of the 253 products in risk class IIa or higher. The gap is widest for new products.
New products list the least evidence
68.2 percent of products launched since 2024 list no peer-reviewed paper.
Seven in ten radiology AI products launched since 2024 list no peer-reviewed study.
CE-marked radiology AI products without a peer-reviewed paper, by year on the market, %
1 Year the vendor says the product came to market. Products per period: 106, 85, 31 and 44; 43 products give no year. Counts only the papers listed on each product's register page.
Source: Health AI Register, crawled 4 October 2026; Lindstead analysis
View data table
| Category | Value |
|---|---|
| 2019 or earlier | 33.0% |
| 2020 to 2021 | 20.0% |
| 2022 to 2023 | 35.5% |
| 2024 to 2026 | 68.2% |
Value: Products without a peer-reviewed paper. Unit: %
New products have had less time to gather studies, so part of the gap will close. Ownership makes less difference than age: 42.4 percent of US-controlled products list no peer-reviewed paper, against 29.3 percent of EU-controlled products and 48.6 percent of the rest.
Earlier research used a stricter method. Antonissen and colleagues searched the literature systematically and found that 34 percent of 173 products had no peer-reviewed evidence in March 2023.8 In 2021 it was 64 percent of 100 products.9 This analysis counts only the papers listed in the register, so the figures are not directly comparable.
How many products still sell on an old certificate?
107 of the 309 radiology products (34.6 percent) are listed with a CE mark under the old Medical Device Directive (MDD). The Medical Device Regulation (MDR) replaced it in 2021. Regulation 2023/607 lets such products stay on the market until 31 December 2028 at the latest, on conditions: the maker had to apply to a notified body by 26 May 2024, sign an agreement by 26 September 2024 and make no significant changes to the design.10
50 of the 107 are class I, which the maker certified itself. The MDR's rule for software puts most diagnostic software in class IIa or higher, which needs a notified body. Older products dominate: half of those on the market since 2019 or earlier use an MDD certificate, and none of the 44 launched since 2024. Obuchowicz and colleagues counted 125 MDD and 80 MDR certificates in the register in October 2024.11 Only 27 products give a certification date, so the register cannot show which certificates still meet the conditions.
What changes under the AI Act?
AI in a medical device that needs a notified body is a high-risk AI system under Article 6(1) of the AI Act.12 For radiology that means MDR class IIa or higher.13 253 of the 309 radiology products (81.9 percent) fall in that group, and the 50 self-certified MDD products will likely join it. The Digital Omnibus moved the start of these obligations to 2 August 2028.14 Products already on the market before then only fall under them after a significant change in design.
A Commission proposal of December 2025 would move medical devices to a lighter part of the AI Act's annex, which would drop the direct high-risk obligations.15 It has not been adopted. The AI Act guide for healthcare covers what applies and when.
Is pathology AI different?
Yes. Pathology AI is an in vitro diagnostic under separate rules, and its market is mostly European. 64 of the 101 products (63.4 percent) come from EU-controlled companies, and 18 (17.8 percent) from US-controlled ones. Ownership moved more: 33 products (32.7 percent) changed owner since 2023, led by Cells IA (14, to ROVI of Spain), Visiopharm (9, to Grundium of Finland) and Paige (9, to Tempus AI of Chicago).
70 of the 101 products (69.3 percent) carry only a self-declared CE mark under the old In Vitro Diagnostic Directive. Depending on their future class they must move to the IVDR by the end of 2027, 2028 or 2029.16 53 of the 101 list no peer-reviewed paper. Matthews and colleagues found 74 percent self-certified among 90 pathology devices in March 2026.17
What does this mean for Dutch hospitals?
Dutch hospitals use several of these products. Amphia wrote in February 2026 that it uses BoneView, Gleamer's fracture tool, and Bravis names Gleamer as well.18,19 Smarthealth reported in July 2026 that Ter Gooi MC uses BoneView, and still described Gleamer as a French company.23 Since March 2026 the tool belongs to RadNet. RadNet's European buying started in the Netherlands: in 2022 it bought Quantib of Rotterdam.24
The government has no overview of these dependencies. The health minister wrote on 11 May 2026 that she has no insight into how far the care sector depends on specific cloud services or suppliers.20 On 30 June 2026 the Tweede Kamer adopted a motion asking the government to map market concentration in care IT, especially of non-European companies, by early 2027.21 Written questions on the CLOUD Act and Dutch care data, filed on 18 August 2026, are still unanswered.22
The Netherlands also makes this software. Nine Dutch companies have 12 products in the register, including ScreenPoint Medical of Nijmegen, whose breast screening product lists 38 peer-reviewed papers. The register itself is Dutch: Romion Health runs it from Utrecht, and it grew out of research at Radboudumc.
What should hospitals ask their AI suppliers?
Ownership can change after a contract is signed. Lindstead recommends five checks:
- Record the ultimate owner of every AI supplier, and check it once a year.
- Ask whether the product runs on premises, and which cloud and region hosts the cloud version.
- For products on an MDD certificate, ask for the notified body agreement and the MDR transition date.
- Ask for the peer-reviewed studies behind each product, and whether any are independent of the vendor.
- Add a change-of-control clause to contracts, with the right to move data and models on a takeover.
The healthcare page covers the rules that apply to hospitals. Lindstead deploys AI on infrastructure the organisation controls, and maps AI Act, GDPR and NIS2 obligations to each AI system.
How was this measured, and what are the limits?
Data. Lindstead saved every public product, company and list page of the Health AI Register on 4 October 2026: 309 radiology and 101 pathology products from 155 companies.1 The crawler followed the register's robots.txt and waited ten seconds between requests. Every figure on this page comes from one script run on those pages.
Ownership. Each company was traced to its ultimate parent, with a source for every row. The country is that parent's headquarters. Investors count only when they own the company outright. An ownership change counts when the buyer or target says the deal has closed.
Fields. Certificate pathway and class come from the register's structured data. Deployment, launch year and studies are reported by vendors. Peer-reviewed papers are counted per product after removing duplicates.
Limitations
- The register is not the whole market. Vendors maintain 255 of the 309 radiology records, and other specialties are not covered.
- Deployment does not name the cloud provider or the data location. US hosting by European vendors is invisible, so every US exposure figure is a floor.
- Evidence counts the papers the register lists. It is not a systematic search and does not show whether a study is independent of the vendor.
- Viz.ai is classed as American: it is a Delaware company that dates its releases from San Francisco. The register lists Tel Aviv. Counted as Israeli, the US total falls from 66 to 60.
- 22 of the 66 US classifications rest on secondary sources such as trade press. Six owners could not be confirmed and keep the country the register gives.
Download the data
Download the data (CSV): one row per company and specialty, 156 rows. Each row has the company's register page, product count, headquarters, ultimate parent and its country, ownership changes from 2023 to 2026, the number of cloud-only, legacy-certificate and unevidenced products, and the source for the ownership.
Cite: Lindstead (2026), Who owns Europe's radiology AI? Register analysis, Health AI Register crawled 4 October 2026. CC BY 4.0 applies to Lindstead's analysis; product data stays with the Health AI Register. Research questions and corrections.
Frequently asked questions
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66 of the 309 CE-marked radiology AI products in the Health AI Register on 4 October 2026 (21.4 percent) are made by companies whose ultimate parent is based in the United States. 19 of those 66 were made by European companies that US buyers took over since 2023.
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Since 2023: Gleamer of Paris and Pixyl of Grenoble (RadNet, through its DeepHealth unit), Kheiron of London (RadNet), icometrix of Leuven (GE HealthCare) and LARALAB of Munich (Abbott). Together they make 19 CE-marked radiology products in the register.
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It applies to providers under US jurisdiction. When a hospital uses the cloud version of a product from a US-controlled vendor, US authorities can order that vendor to hand over data in its possession, custody or control, wherever it is stored. Most radiology AI products can also run on hospital premises: 229 of the 261 products that state their deployment.
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AI in a medical device that needs a notified body is high-risk under Article 6(1) of the AI Act. In the register that covers 253 of 309 radiology products (class IIa or higher). After the Digital Omnibus, Regulation (EU) 2026/1744, those obligations apply from 2 August 2028.
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Under Regulation (EU) 2023/607, until 31 December 2028 at the latest, and only if the maker applied to a notified body under the MDR by 26 May 2024, signed an agreement by 26 September 2024 and made no significant changes to the design or intended purpose. 107 of 309 radiology products in the register are still listed with an MDD certificate.
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Yes. The CSV on this page has one row per company with Lindstead's ownership research, product counts and sources. Lindstead's analysis is published under CC BY 4.0. Cite Lindstead (2026) with a link to this page. Product-level data stays with the Health AI Register.
Sources
- Health AI Register (Romion Health, Utrecht), all public radiology and pathology product, company and list pages, crawled 4 October 2026. healthairegister.com
- RadNet, RadNet acquires Gleamer, making RadNet's DeepHealth the largest provider of radiology clinical AI solutions worldwide, 2 March 2026. www.radnet.com/about-radnet/news/radnet-acquires-gleamer-making-radnet-s-deephealth-the-largest-provider-of-radiology-clinical-ai-solutions-worldwide
- GE HealthCare, GE HealthCare announces intent to acquire icometrix, 10 September 2025; closing on 7 November 2025 reported in its annual report for 2025. investor.gehealthcare.com/news-releases/news-release-details/ge-healthcare-announces-intent-acquire-icometrix-strengthen
- AuntMinnie, Gleamer acquires Pixyl, Caerus Medical, 11 March 2025. www.auntminnie.com/industry-news/ma/article/15739618/gleamer-acquires-pixyl-caerus-medical
- DeepHealth, DeepHealth expands its AI-powered cancer diagnostic and screening portfolio with the acquisition of Kheiron, October 2024. deephealth.com/press-releases/deephealth-expands-its-ai-powered-cancer-diagnostic-and-screening-portfolio-with-the-acquisition-of-kheiron/
- Dechert, Dechert advises the shareholders of LARALAB GmbH on sale to Abbott, October 2025. www.dechert.com/content/dechert/en/knowledge/news/2025/10/dechert-advises-the-shareholders-of-laralab-gmbh-on-sale-of-lara.html
- 18 U.S.C. 2713, Required preservation and disclosure of communications and records (CLOUD Act). www.law.cornell.edu/uscode/text/18/2713
- Antonissen, van Leeuwen et al., European Radiology, 24 July 2025: 173 products as of 31 March 2023. pmc.ncbi.nlm.nih.gov/articles/PMC12711992/
- van Leeuwen et al., Artificial intelligence in radiology: 100 commercially available products and their scientific evidence, European Radiology, 2021. pmc.ncbi.nlm.nih.gov/articles/PMC8128724/
- Regulation (EU) 2023/607 amending the MDR transitional provisions. data.europa.eu/eli/reg/2023/607/oj
- Obuchowicz et al., Diagnostics, January 2025: register data of October 2024. pmc.ncbi.nlm.nih.gov/articles/PMC11816879/
- Regulation (EU) 2024/1689 (AI Act), Article 6(1) and Annex I. data.europa.eu/eli/reg/2024/1689/oj
- MDCG 2025-6 / AIB 2025-1, interplay between the MDR, IVDR and AI Act, June 2025. health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf
- Regulation (EU) 2026/1744 (Digital Omnibus on AI), 8 July 2026. data.europa.eu/eli/reg/2026/1744/oj
- European Commission, proposal to revise the MDR and IVDR, COM(2025) 1023, 16 December 2025. health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf
- Regulation (EU) 2024/1860 amending the IVDR transitional provisions. data.europa.eu/eli/reg/2024/1860/oj
- Matthews et al., medRxiv, 26 March 2026: CE-marked AI devices in pathology. www.medrxiv.org/content/10.64898/2026.03.23.26349089v1.full
- Amphia, AI helpt afdeling radiologie bij snellere beoordeling van mogelijke botbreuken, 3 February 2026. www.amphia.nl/nieuws/ai-helpt-afdeling-radiologie-bij-snellere-beoordeling-van-mogelijke-botbreuken
- Bravis ziekenhuis, Radiologie en AI. www.bravis.nl/radiologie-en-ai
- Minister of Health (VWS), Kamerstuk 27529 nr. 359, 11 May 2026. www.tweedekamer.nl/downloads/document?id=2026D21291
- Motion Bushoff and Kathmann, Kamerstuk 27529 nr. 378, adopted 30 June 2026. www.tweedekamer.nl/downloads/document?id=2026D33305
- Written questions Claassen and Markuszower on the CLOUD Act and Dutch care data, 18 August 2026. www.tweedekamer.nl/downloads/document?id=2026D38528
- Smarthealth, AI bij röntgenfoto's geeft sneller duidelijkheid, 10 July 2026. smarthealth.live/2026/07/10/ai-bij-rontgenfotos-geeft-sneller-duidelijkheid/
- ICT&health, AI-startup Quantib gekocht door Amerikaanse RadNet, 3 February 2022. www.icthealth.nl/nieuws/ai-startup-quantib-gekocht-door-amerikaanse-radnet
Method: all register figures from Lindstead's analysis of the Health AI Register, crawled 4 October 2026; context sources opened on the same date. This page is general information, not medical or legal advice. Corrections: contact@lindstead.com.