The Surgical AI Claims Report
CLAIMS VERIFICATION LEDGER
A deep dive into five FDA-cleared surgical AI systems. We read the filings and the clinical data so you can see past the press release.
Systems Covered
- Asensus Surgical — ISU (Intelligent Surgical Unit)
- Medtronic — Touch Surgery Enterprise
- Proximie — The Digital OR Layer
- Theator — Surgical Intelligence Platform
- Caresyntax — Digital Surgery Intelligence
Instant lifetime access to the PDF guide and claims ledger.
What's Inside
The Claim
We extract the exact marketing and clinical claims made by each manufacturer, focusing on technical AI specifications.
The Filing
We cross-reference these claims against their FDA 510(k) or De Novo filings to see what was actually cleared for use.
The Verdict
A direct comparison of marketing vs. clearance, highlighting gaps in "real-time" or "autonomous" claims.
A Comparative Summary
A leaderboard showing which platforms provide the most robust clinical evidence for their AI capabilities.
Why the Pathway Matters
Surgical AI currently lives in a regulatory grey area. Manufacturers often market Level 3 autonomy while holding Level 1 clearances. This gap creates clinical and legal risk for hospitals.
By understanding the FDA pathway (predicates used, clinical endpoints, and labeling constraints), surgeons can better evaluate whether a tool integrates into their workflow or adds a liability.
This report provides the technical literacy needed to navigate the next wave of OR intelligence without the marketing polish.
Read the Filings, Not the Press Release
Full Report & Verification Ledger — $49
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