Look beyond the chat window
The FDA maintains a list of AI-enabled medical devices authorized for marketing in the United States. Its entries include devices across fields such as radiology and cardiovascular care. This is a way to explore actual device records rather than treating every mention of “AI in health” as the same technology. [1]
- Find the device
- Read its intended use
- Examine public information
From a name to a concrete purpose
Each listed submission links to an FDA database record with publicly releasable information. The agency describes a focused review of safety and effectiveness for the device’s intended use. [1] A useful reading question is therefore: what particular task is this device intended to perform?
A window, not a complete inventory
FDA says the list is not comprehensive and that public summaries do not include most of the information submitted in an application. [1] Our interpretation: the list is useful for discovery, but it cannot establish which tools your own care team uses or whether a device suits your situation.
A conversation worth having
If AI comes up during care, you could ask what task it supports and how its output is used in your care. Those are suggested conversation starters, not treatment recommendations. This story explains a public resource; it does not rate devices or recommend a medical decision.
Go a little deeper
Optional reading · about 1 more minute
Explore one record
At the FDA source below, choose a submission number to open its record and available public information. Read the intended use before interpreting a product name. A listing is not a blanket authorization for every use someone might imagine. [1]
Original sources
Attributed synthesis, not original reporting. Examples labeled hypothetical or illustrative are explanatory. Reviewing a source does not independently validate its findings.
- FDA: Artificial Intelligence-Enabled Medical Devices ↗
Living resource reviewed September 11, 2026. List introduction, limitations and sample table entries reviewed; individual device submissions not independently evaluated.
