Kintsugi closes after de novo denial, open sources speech AI
California startup Kintsugi is shutting down after not getting FDA clearance through the De Novo pathway for its AI that detects depression and anxiety from speech.
After seven years of building software to spot mental health signals in how people talk, the team decided to release most of its tech as open source so others can use and improve it.
Founder Grace Chang highlights regulatory challenges
Kintsugi struggled with tough FDA rules designed for traditional medical devices, which didn't fit its flexible AI models.
Founder Grace Chang said working with regulators was a big challenge and stressed how important it is to help them understand new tech.
While some features, like deepfake detection, are staying private for security reasons, Chang hopes others will build on what Kintsugi started, despite the tricky mix of startups and medical regulations.