Kintsugi AI Depression Detection Startup Shuts Down After 7-Year FDA Wait — Open-Sources $30M of Research

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Kintsugi, the voice-based mental health AI startup, is shutting down after burning through $30M and nearly four years navigating the FDA De Novo clearance process without success. Their AI detected 33% moderate-to-high depression vs 3% from standard questionnaires, but standard VC timelines (18-24 months to revenue) are incompatible with medical device approval horizons. The company is open-sourcing all technology and pivoting remaining resources toward deepfake detection, where identical audio analysis capabilities face zero regulatory barriers.