Why it matters
The list can be used as a structured baseline for monitoring category growth, specialties, manufacturers, and regulatory pathways rather than relying on marketing claims about 'medical AI'.
Decision implication
Ingest the authorized-device list into P4L's Intelligence Graph and compare authorization with real-world adoption, evidence, workflow, and postmarket monitoring.
Who or what is affected
- FDA
- device manufacturers
- health systems
- investors
- clinicians
Evidence and sources
Decision priority: Watch
Source authority: Primary/authoritative · official FDA source
Evidence design: Program record
Applicability: Direct
Confidence for the stated claim: High
Freshness: Current
P4L distinguishes the sourced record from interpretation. Program inclusion, participation, funding, proposal status, or a public listing does not by itself establish clinical effectiveness, endorsement, coverage, or scaled adoption unless the cited source specifically establishes it.
For this decision
Clinicians · Innovators · Health-system leaders · Policymakers
What P4L is watching next
- New authorizations
- specialty mix
- update cadence
- postmarket evidence.
Related proof records
None recorded.
Record provenance
- Last verified
- 2026-09-03
- Source updated
- 2026-06-16
- Revision state
- Version 1.1 corrects the observation date to FDA’s June 16, 2026 content-current date, adds non-comprehensive-list semantics and inclusion/omission limits, and records the September 3, 2026 re-verification.
- Status
- Current non-comprehensive FDA authorization-list resource · periodically updated
- Freshness
- Current
- Version
- 1.1
- Stable ID
- SIG-2026-023