Limbic Becomes First AI-Led Mental Health Care Company Selected For FDA TEMPO Pilot

Limbic was selected by the U.S. Food and Drug Administration (FDA) for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot. Through the pilot, Limbic will introduce Unpacked, a health care professional-supervised and artificial intelligence (AI)-driven mental health service for eligible Medicare beneficiaries with clinically significant depression or anxiety. The service will provide cognitive behavioral therapy (CBT) through scheduled telephone conversations with an AI voice agent, with licensed health care professionals overseeing each person’s care.

The TEMPO pilot will take place in collaboration with the Centers for Medicare & Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic . . .