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

AIReportScienceIt’s not easy to get depression-detecting AI through the FDAInstead, a mental health startup shut down and open-sourced its tech.Instead, a mental health startup shut down and open-sourced its tech.by Robert HartApr 2, 2026, 3:33 PM UTCLinkShareGiftImage: Cath Virginia / The VergeRobert Hart is a London-based reporter at The Verge covering all things AI and a Senior Tarbell Fellow. Previously, he wrote about health, science and tech for Forbes.For the past seven years, the California-based startup Kintsugi has been developing AI designed to detect signs of depression and anxiety from a person’s speech. But after failing to secure FDA clearance in time, the company is shutting down and releasing most of its technology as open-source. Some elements may even find a second life beyond healthcare, like detecting deepfake audio.Mental health assessments still largely rely on patient questionnaires and clinical interviews, rather than the lab tests or scans common in physical medicine. Instead of focusing on what someone is saying, Kintsugi’s software analyzes how it is being said. The idea isn’t new — speech patterns like pauses, sentence structure, or speed are known indicators of various mental health issues — but Kintsugi says its AI can pick up subtle shifts that may be less obvious to human observers, though it has not publicly detailed exactly which features drive its models’ predictions. In peer-reviewed research, the company reported results broadly in lin...