FDA has cleared approximately 1,250 AI/ML-enabled medical devices through May 2026. The Predetermined Change Control Plan (PCCP) pathway is now operational and being used in nearly 30 percent of new submissions. FDA Commissioner Martin Makary announced a new risk-based framework on 6 January 2026, with the ADVOCATE programme targeting first FDA-authorised agentic AI in healthcare. This page consolidates the device-clearance count by category, the PCCP adoption, hospital deployment statistics, and the regulatory roadmap.
Key Findings
- FDA has cleared approximately 1,250 AI/ML-enabled medical devices through May 2026 per the FDA AI/ML-enabled medical devices list. Approximately 80 percent are in radiology.
- The Predetermined Change Control Plan (PCCP) pathway, finalised in late 2023, is being used in approximately 30 percent of new AI device submissions in 2026, enabling pre-authorised model updates without requalification.
- FDA Commissioner Martin Makary announced a new risk-based AI framework on 6 January 2026, prioritising faster review for low-risk AI/SaMD devices and clearer expectations for higher-risk and generative-AI-enabled devices.
- The ADVOCATE programme targets the first FDA-authorised agentic AI in healthcare, with the lead applicant in pre-submission as of Q1 2026.
- Approximately 80 percent of U.S. hospitals report using at least one AI application in 2024-2025 (per AHA survey data); the proportion has risen further in 2026.
FDA AI Device Approvals by Category
| Category | Approved Devices (cumulative through May 2026) |
|---|---|
| Radiology / imaging | ~1,000 |
| Cardiology | ~90 |
| Ophthalmology | ~30 |
| Neurology | ~25 |
| Pathology | ~25 |
| Gastroenterology / urology | ~20 |
| Hematology | ~15 |
| Other (orthopaedics, dental, etc.) | ~45 |
Top Vendors by FDA Cleared AI Devices
| Vendor | Approximate Cleared Device Count |
|---|---|
| GE HealthCare | ~80 |
| Siemens Healthineers | ~70 |
| Aidoc | ~30 |
| Philips Healthcare | ~60 |
| Canon Medical | ~30 |
| iCAD | ~25 |
| HeartFlow | ~20 |
| Riverain Technologies | ~15 |
| RapidAI | ~15 |
| Annalise.ai | ~12 |
| Viz.ai | ~12 |
Hospital AI Deployment Statistics
| Metric | Value (2024-2026) |
|---|---|
| Hospitals using at least one AI application | ~80% |
| Hospitals using AI in radiology workflow | ~65% |
| Hospitals using AI in clinical documentation (ambient scribing) | ~45% |
| Hospitals using AI in revenue cycle management | ~55% |
| Hospitals using AI in patient triage / acuity | ~30% |
| Health systems with a dedicated AI governance committee | ~62% |
| Health systems with a Chief AI Officer or equivalent | ~24% |
2026 FDA AI Regulatory Programmes
| Programme | Status May 2026 |
|---|---|
| PCCP (Predetermined Change Control Plans) | Operational; ~30% of submissions use PCCP |
| ADVOCATE (first agentic AI authorisation pathway) | Lead applicant in pre-submission |
| Risk-based AI framework (Makary 6 Jan 2026) | Implementation rollout Q1-Q2 2026 |
| Generative AI in medical devices guidance | Draft expected H2 2026 |
| Total Product Life Cycle (TPLC) framework | Active across device categories |
Strategic Context
Three structural patterns shape the 2026 FDA AI landscape. First, radiology dominance continues: approximately 80 percent of cleared devices are in radiology, reflecting both the maturity of imaging AI and the FDA\u2019s relative comfort with image-classification tasks. Second, PCCP adoption is moving the regulatory model from one-time approvals to lifecycle-managed AI: vendors with mature MLOps stacks gain a meaningful advantage in deployment velocity. Third, agentic AI is the next regulatory frontier: ADVOCATE is the most-watched programme because it will set precedent for whether multi-step AI agents can be regulated under existing SaMD frameworks or require new regulatory categories.
Brand Visibility Implications
FDA AI regulation is a high-traffic procurement and policy research category. AI assistant queries about FDA AI approvals, PCCP pathway, hospital AI deployment, and adjacent topics drive sustained traffic from health-system procurement, regulatory affairs, AI safety, and investor audiences. Brands selling regulatory affairs consulting, MLOps for clinical AI, AI validation tooling, and adjacent products face strong AI-mediated discovery surface for this category.
Methodology
Device clearance counts from the FDA AI/ML-enabled medical devices list. Hospital deployment statistics from American Hospital Association and Health Affairs survey data. Regulatory programme status from FDA announcements and CDRH disclosures. Updated quarterly.
How Presenc AI Helps
Presenc AI monitors brand visibility on FDA AI and clinical AI deployment queries across ChatGPT, Claude, Gemini, and Perplexity. For regulatory affairs consultants, MLOps-for-clinical-AI vendors, AI validation tooling brands, and clinical deployment partners, the platform identifies the prompts driving procurement research and the gaps where new content unlocks share of voice.