Healthcare AI InsightsStudies in healthcare AI · by Chi-way Li

Healthcare AI Insights publishes independent studies of how AI enters healthcare. Each study runs in phases, with a report, articles and open data.

Study 1Medical AI · Phase 1 of 5: The money

Cleared to Paid

The FDA has cleared 1,614 AI medical devices. Only 79 have ever had a billing code, or a similar route, that lets insurers pay each time the AI is used. A study of who pays for medical AI, and why.

Read the studyOpen Phase 1: The money

Phase 1: The money published · by Chi-way Li

Only 79 of 1,614 have ever had a per-use payment route

FDA AI-enabled devices, one square per device

74 devices still have a per-use payment route, 5 had one that has ended, and 1,535 have never had one.
  • Per-use route in force today (74)
  • Route has ended (5)
  • Never had one (1,535)

Sources: FDA; CMS; Medicare contractors; makers' coding guidesHealthcare AI Insights

Paid from a buyer's budget3 in 4FDA AI devices, paid for out of buyers' own budgets, mostly hospitals and imaging groups Medicare payments to doctors, 2024$10.3Mon AI billing codes; 96% for coronary CT Payment cases36compared across the US, China, Germany and the UK

Phase 1: The money · Articles

Inside the study

Start hereOverviewThe study's question, its five phases and the Phase 1 lead article. ReportPhase 1: The moneyWho pays for every FDA AI device: interactive charts, payment routes, four countries, and a lookup of all 1,614 devices. DataLandscapeWhat the FDA is clearing: clearances by year, specialties, imaging types, competition and what summaries disclose. How it is madeMethodRun like a consulting project, staffed by AI agents: written evidence rules, a red-team check and published error rates.

The full study as a working paper: Who Pays for Medical AI? Payment Routes for 1,614 FDA-Authorized AI Devices and Where the Money Goes (SSRN, 2026)

Healthcare AI InsightsAcross all studies

All studies

  1. Study 1 · Phase 1 of 5: The money

    Cleared to Paid

    The commercialization of medical AI, in five phases: the money, the buyer, the builders, the verdict and the next wave.

  2. Study 2 · In preparation

    Next study

    To be announced.

About the author

I run the research like a consulting project staffed by AI agents: each works to written evidence rules, a separate agent tries to break their answers, and I make the judgment calls. I'm a biomedical engineer (B.S., Penn State; M.Eng., Cornell) with an MBA from Yale. I've worked in commercial strategy consulting for life-sciences companies and as a medical AI product manager, on global teams in the US, China and Asia Pacific. This is an independent project; views are my own and not those of any employer.

Chi-way Li · Comments and corrections on LinkedIn