FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy
[REGULATORY ACTION]Oct 8, 2025 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
REGULATORY ACTION
Event Date
Oct 8, 2025
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA cleared a software update for the Intuitive Surgical Ion endoluminal system introducing AI-powered enhanced navigation that addresses CT-to-body divergence during lung biopsies, plus integrated tomosynthesis imaging capabilities. The clearance expands Ion capabilities for minimally invasive peripheral lung biopsy.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://investor.intuitivesurgical.com/news-releases/news-release-details/intuitive-expands-ai-and-advanced-imaging-integration-ion
https://investor.intuitivesurgical.com/news-releases/news-release-details/intuitive-expands-ai-and-advanced-imaging-integration-ion
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Details
Incident Context & FAQ
What happened in FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy?
FDA cleared a software update for the Intuitive Surgical Ion endoluminal system introducing AI-powered enhanced navigation that addresses CT-to-body divergence during lung biopsies, plus integrated tomosynthesis imaging capabilities. The clearance expands Ion capabilities for minimally invasive peripheral lung biopsy.
When did this incident occur?
The incident is recorded as occurring on October 8, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.