It’s not easy to get depression-detecting AI through the FDA
infonews
industrypolicy
Source: The Verge (AI)April 2, 2026
Summary
Kintsugi, a California startup, spent seven years developing AI to detect depression and anxiety by analyzing how someone speaks rather than what they say. The company is shutting down after failing to get FDA (Food and Drug Administration, the U.S. agency that approves medical products) clearance, though it is releasing its technology as open-source software so others can use and build on it.
Classification
Attack SophisticationModerate
AI Component TargetedModel
Affected Vendors
Monthly digest — independent AI security research
Original source: https://www.theverge.com/ai-artificial-intelligence/905864/depression-detecting-ai-kintsugi-clinical-ai-startup-shut-down
First tracked: April 2, 2026 at 08:00 PM
Classified by LLM (prompt v3) · confidence: 75%