AI Device Intelligence — Zero Noise

FDA intelligence built exclusively for AI medical devices.

Every clearance, predicate, guidance, and enforcement action — filtered to AI and ML devices only. No orthopedic implants. No wound care. No noise.

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Live Clearance Feed LIVE
✓510(k) K243821 cleared — Viz.ai stroke detection AI2 min ago
✓De Novo DEN220043 — new product code QMF created1 hr ago
⚠Warning letter — [Company redacted] AI diagnostic system3 hrs ago
✓New PCCP approved — algorithm retrain without new 510(k)Yesterday
✓510(k) K251934 cleared — qXR-Detect chest AI2 days ago

ⓘ AIFDA Intel is an independent commercial platform and is not affiliated with, endorsed by, or connected to the U.S. Food and Drug Administration.

950+
AI/ML devices cleared by FDA
47
De Novo decisions creating new AI product codes
12
FDA guidance documents on AI regulation
3×
YoY growth in AI device submissions

The Problem

The FDA data exists. Relevance is the problem.

01

FDA publishes a list. You need a database.

FDA's AI device spreadsheet has no filters, no predicates, no context, no history. You copy it into Excel and search manually. Every. Single. Time.

02

General platforms bury you in irrelevant data.

Citeline and similar tools cover 50,000+ devices. You need intelligence on ~1,000 AI-specific ones. Filtering through everything else costs hours you don't have.

03

Your competitors clear while you're still searching.

Every 510(k) summary is public. But by the time you find it, your competitor has already cited it as a predicate. AIFDA Intel alerts you the moment it's cleared.

Who It's For

Built for everyone building or betting on AI medical devices.

AI Medical Device Startups

  • Know which AI predicates are available for your indication
  • Track PCCP patterns before you design your ML pipeline
  • Get alerted the moment a competitor clears

Regulatory Consultants

  • Brief clients with current competitive context, not static spreadsheets
  • Track FDA's enforcement posture on AI devices
  • Monitor guidance changes across all your client indications at once

Investors & Due Diligence Teams

  • Assess regulatory risk before term sheets
  • Understand market positioning — first mover vs crowded indication
  • Historical clearance velocity data by device category

In-House RA Teams at Large Device Cos

  • Monitor the full AI device landscape without manual FDA searches
  • Early warning on enforcement trends
  • Regulatory timeline estimates based on similar cleared devices

The Platform

Every AI device signal, connected and current.

AI/ML Clearance Database

950+ cleared devices, fully tagged. Filter by indication, device class, algorithm type, and clearance date.

Predicate Intelligence

Find which AI devices are being used as predicates and how often. Built on the same infrastructure as Predicase.

Competitive Intelligence

See who dominates each AI indication. First-mover analysis, clearance velocity, investor-grade charts.

FDA Guidance Monitor

Every AI-related FDA guidance, draft, and action plan in one place. Plain-English summaries included.

Smart Alerts

Get notified when a competitor clears, when FDA publishes new guidance for your product code, or when a PCCP is approved in your space.

See all 9 features →

Built for AI devices. Only AI devices.

14-day free trial on Professional. No credit card required.

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Not building an AI/ML device? Predicase searches the full FDA 510(k) database — all 175,000+ clearances, every device type. Try Predicase →