{
  "signal_id": "SIG-2026-023",
  "observed_date": "2026-07-01",
  "category": "AI Medical Devices + Transparency",
  "title": "FDA's AI-enabled medical-device list remains a current transparency and landscape resource",
  "what_changed": "FDA maintains a public list intended to identify AI-enabled medical devices authorized for marketing in the United States and to provide transparency into the regulated landscape.",
  "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'.",
  "affected_actors": [
    "FDA",
    "device manufacturers",
    "health systems",
    "investors",
    "clinicians"
  ],
  "decision_implication": "Ingest the authorized-device list into P4L's Intelligence Graph and compare authorization with real-world adoption, evidence, workflow, and postmarket monitoring.",
  "status": "Current regulatory resource",
  "evidence_class": "E5 — official FDA source",
  "impact": 4,
  "immediacy": 3,
  "relevance": 5,
  "novelty": 4,
  "adoption_leverage": 5,
  "priority_score": 85,
  "sources": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "public_slug": "/signal/2026-07-01-fda-ai-device-landscape/",
  "watch_conditions": [
    "New authorizations",
    "specialty mix",
    "update cadence",
    "postmarket evidence."
  ],
  "last_verified": "2026-08-08",
  "version": "1.0"
}