Case Study
Let's Talk Risk! Podcast
Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
- Published
- September 8, 2025
- Duration
- 14:37
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses ai-regulation.
Summary
Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk manag…
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Show notes
Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk management point of view. Here are a few key highlights* The Landscape: 1,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events i
Themes
- ai-regulation