GE Healthcare has 93 FDA-authorised AI devices, the most of any company, ahead of Siemens Healthineers' 82

What the chart shows

Large imaging manufacturers hold the most FDA-authorised AI-enabled devices. GE Healthcare has 93 and Siemens Healthineers 82, more than twice the next companies: Shanghai United Imaging Healthcare (38), Philips Healthcare (36) and Canon Medical Systems (35).

Aidoc Medical (30) is next. The 15 companies shown hold 424 devices between them, under a third of the 1,357 on the FDA’s list; the AI Index says most companies with an authorised device hold only one or two.

Key numbers

How to read it

• Counts by company name as listed by the FDA; related companies may be listed separately.
• The AI Index text gives the number of companies with at least one device as 626 in one place and 693 in another; the data covers only these 15.
• Authorised covers every route on the FDA’s list, mostly 510(k) clearance; the AI Index’s chart title says ‘approved’.