LIMBIC LIMITED

FDA Adds Two Behavioral Health Firms to TEMPO Pilot, Including an AI Voice Agent for Talk Therapy

- The FDA has expanded its TEMPO pilot to four participants, adding two behavioral health companies, Limbic and SonderMind, alongside Cadence Solutions and Dexcom. - Limbic's "Unpacked" delivers cognitive behavioral therapy for depression and anxiety through an AI voice agent, overseen by a clinician, to Medicare beneficiaries. - The FDA states plainly that the effectiveness of these devices for their intended uses has not yet been evaluated, and participation relies on enforcement discretion rather than approval. - Both devices carry extensive contraindication lists, including suicidality, psychosis, and dementia, underscoring that these tools sit alongside clinical care rather than replacing it.