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AI newsThe story, in brief

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

Seven years. $millions invested. Kintsugi's depression-detecting AI just hit the FDA wall and shut down.

Reporting by The Verge AI 1 min brief
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The KeyNews take

Why it matters

Regulatory hurdles remain a major obstacle for healthcare AI startups, even with promising technology. Kintsugi's failure to secure FDA clearance after 7 years highlights the challenges of bringing mental health AI to market.

The key facts

4 to know

  1. Seven years of development

  2. Company shutting down due to FDA clearance failure

  3. Technology being released as open-source

  4. Pivot potential to deepfake audio detection

Go to the source

The Verge AItheverge.com

Publisher excerpt: 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…
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