The U.S. Food and Drug Administration (FDA) has selected London-based Limbic as the first AI-led mental healthcare provider for its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot. Starting Aug. 27, its Unpacked service will provide clinician-supervised AI therapy to eligible Medicare patients with depression and anxiety.

According to a press release, the service will deliver cognitive behavioral therapy (CBT) through scheduled telephone conversations with an AI voice agent, overseen by licensed clinicians supervising each patient’s care from beginning to end.

This is happening alongside the Centers for Medicare & Medicaid Services’ (CMS) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, which pays participating providers based on whether patients improve rather than how many services they receive. TEMPO will allow the FDA to gather real-world data on the technology's safety and outcomes.

“This is not AI replacing a therapist,” said Patricia Taylor, licensed clinical psychologist and head of Clinical Operations at Limbic, in a statement. “Unpacked is a clinical service, and a clinician remains responsible for every patient. AI allows our team to provide immediate care to far more people than traditional models.”