What FDA Clearance Means (and Doesn't)
FDA clearance for an AI health tool typically falls into one of several pathways. 510(k) clearance means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device for a specified intended use. It is the most common pathway and the one most AI imaging tools have used. De Novo authorization is for novel low-to-moderate-risk devices without an existing predicate — Viz.ai received the first AI triage software De Novo clearance in 2018. Premarket Approval (PMA) is the highest bar, used for high-risk devices, and is rare in current AI health. Breakthrough Device Designation is not a clearance — it is a status that gives expedited FDA engagement for devices addressing serious or life-threatening conditions.
FDA clearance authorizes a specific intended use, not general capability. A clearance for "AI-powered triage notification of large vessel occlusion in suspected stroke" does not authorize the same system to triage hemorrhagic stroke unless that indication is also cleared. When evaluating AI health tools, always read the actual indication for use, not the marketing summary.
Clearance also does not equal clinical efficacy in your specific patient population. FDA review evaluates whether the device performs as claimed, not whether deploying it will improve outcomes in your hospital. Local validation is still essential.
The Leaders in 2026
Viz.ai — First AI Triage De Novo and 50+ Clearances
Viz.ai received the first FDA De Novo clearance for AI triage software in 2018 (DEN170073) for the detection of suspected large vessel occlusion in stroke. It now holds 50+ FDA 510(k) clearances across stroke (LVO), intracranial hemorrhage, aneurysm, pulmonary embolism, aortic disease, subdural hemorrhage, and cardiac analysis — the broadest regulatory portfolio in medical imaging AI. Viz.ai also established the Medicare NTAP reimbursement pathway for AI triage software, which is a meaningful precedent for AI device economics.
Aidoc — First Comprehensive Foundation Model Clearance
Aidoc received FDA 510(k) clearance in January 2026 for the first comprehensive body CT triage foundation model, covering 14 acute conditions (11 new plus 3 existing) from a single CT scan with reported 97% mean sensitivity and 98% mean specificity. This is a regulatory milestone — the first time the FDA has cleared a single foundation model AI for multiple radiology indications, rather than requiring separate clearances for each condition. Aidoc is deployed in 1,200+ medical centers globally including 7 of the top 10 US hospitals.
Tempus AI — Multiple Cleared Genomic and Cardiac AI Products
Tempus AI holds multiple FDA 510(k) clearances spanning genomic sequencing and cardiac AI: Tempus xT (DNA next-generation sequencing IVD), Tempus xR IVD (RNA NGS, cleared September 2025), Tempus Pixel (cardiac MRI AI), and Tempus ECG-Low EF (detection of reduced ejection fraction from a standard ECG). The combination of cleared genomic IVDs and cleared imaging AI under one corporate umbrella is unusual and gives Tempus unusual breadth across precision medicine.
PathAI — First DDT Biomarker Qualification for AI Pathology
PathAI's regulatory portfolio is the strongest in AI pathology. AISight Dx received FDA 510(k) clearance (K243391) for primary pathology diagnosis in June 2025 with a Predetermined Change Control Plan — the first PCCP for digital pathology, allowing prespecified model updates without re-clearance. AIM-MASH AI Assist received FDA Drug Development Tool Biomarker Qualification in December 2025, the first AI pathology tool to be qualified as a DDT for use in MASH clinical trials. PathAssist Derm received Breakthrough Device Designation in March 2026.
The DDT qualification is particularly significant: it means the FDA accepts AIM-MASH outputs as valid biomarker measurements in clinical trials, which goes beyond standard 510(k) clearance for the relevant use case.
What We Did NOT Include
This list intentionally excludes AI tools that do not have FDA device clearance. That includes most ambient AI medical scribes (Abridge, Suki, Freed, DeepScribe, Nuance DAX Copilot), most AI EHR features (athenahealth AI, DrChrono AI), all AI mental health chatbots that previously needed clearance (Wysa holds Breakthrough Device Designation but not full clearance), and consumer symptom checkers (Ada Health, K Health). These products are not FDA-cleared because they generally fall outside the FDA device definition — ambient documentation aids and clinical decision support tools that meet the 21st Century Cures Act non-device CDS criteria are exempt from FDA device regulation.
Lack of FDA clearance does not mean a product is unsafe or unvalidated. It generally means the product does not make a diagnostic, therapeutic, or treatment claim that requires clearance. For ambient AI scribes, the "documentation aid" framing is what keeps them outside the FDA device pathway, and the FDA's mid-2025 guidance clarifying AI scribe regulatory classification confirmed this.
How to Read Regulatory Status as a Buyer
Three questions to ask any AI health vendor about FDA status:
- What is the exact intended use cleared by FDA? Marketing language often expands beyond the cleared indication. Ask for the K-number and read the indication for use statement directly.
- Do you have a Predetermined Change Control Plan (PCCP)? A PCCP allows the vendor to update the model on a predefined schedule without re-clearance. PathAI's AISight Dx PCCP is the first in digital pathology and is a sign of regulatory maturity.
- What is your post-market surveillance and performance monitoring approach? AI models drift. Vendors with mature governance can describe their monitoring program clearly. Aidoc's continuous performance monitoring is a useful reference standard.
The Bottom Line
FDA-cleared AI health tools cluster in radiology, pathology, and cardiac imaging because those are the categories where AI is making decisions about specific clinical indications that require regulatory oversight. Viz.ai and Aidoc lead in radiology triage, Tempus AI leads in genomic and cardiac AI, and PathAI leads in pathology with the broadest and most innovative regulatory portfolio in its category. For health systems building an AI strategy, these are the safe starting points where the regulatory question is settled. For everything else, the regulatory framing may be accurate but is not a substitute for local validation.