It’s not easy to get depression-detecting AI through the FDA | The Verge

This page reports that Kintsugi, a California-based startup developing AI to detect depression and anxiety from speech, is shutting down after failing to secure FDA clearance. Over seven years, the company created software analyzing speech patterns—pauses, sentence structure, speed—as indicators of mental health issues. The AI aimed to complement or replace traditional self-report screening tools like the PHQ-9. Peer-reviewed research showed results comparable to established tools, but the company could not achieve FDA approval in time. Kintsugi is open-sourcing its technology, with some applications potentially extending beyond healthcare, such as deepfake audio detection.