Limbic Becomes First AI-Led Mental Healthcare Company Selected for FDA TEMPO

Limbic’s Unpacked will be the first company to deliver clinician-supervised AI cognitive behavioral therapy to Medicare patients with depression and anxiety

NEW YORK & LONDON--(BUSINESS WIRE)--Limbic is the first AI-led mental healthcare company selected by the U.S. Food and Drug Administration for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot. Through the pilot, Limbic will introduce Unpacked, a clinician-supervised AI-led mental health service for eligible Medicare beneficiaries with clinically significant depression or anxiety. 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.

“The shortage of mental health professionals is particularly hard on older adults, who are under-represented among people receiving psychotherapy,” said Ross Harper, co-founder and CEO of Limbic. “We’ve shown that AI can help close this gap, but only if deployed responsibly, with rigorous clinical evidence, clinician oversight, and accountability for patient outcomes. TEMPO and ACCESS give us a pathway to put those principles into practice at scale.”

TEMPO allows selected manufacturers to offer new technologies while gathering real-world data for FDA evaluation, while CMS ACCESS introduces a new payment model that rewards providers for delivering improved patient outcomes, rather than for the volume of services delivered.

Across Medicare and Medicaid combined, 73% of providers are unable to accept new patients, mainly because their caseloads are full. Unpacked is designed to fill this void with immediate access to clinically-supported care.

With Unpacked, AI and clinicians work together. Specialized AI agents conduct scheduled CBT sessions between clinician contacts. Clinicians review each patient's progress and session content, receive real-time safety alerts, and adjust or take over the course of treatment at their discretion. Where a patient is assessed as being at immediate risk, the clinician escalates through established clinical protocols. This hybrid model provides a scale of care delivery beyond current constraints.

“This is not AI replacing a therapist,” said Patricia Taylor, licensed clinical psychologist and Head of Clinical Operations at Limbic. “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.”

Through FDA TEMPO, Limbic will gather data on outcomes, safety and how patients use the service. This will help the FDA and CMS assess how clinician-supervised AI care works as part of everyday care.

Unpacked will start rolling out on August 27, 2026 at: https://limbic.ai/unpacked.

About Limbic

Limbic builds clinical AI to make high-quality mental healthcare available to everyone. From intake, through treatment, to recovery, Limbic extends the reach of the clinical teams who direct their care.

Deployed at scale across the U.S. and U.K., Limbic supports more than 820,000 patients. Limbic was the first mental health AI certified as a Class IIa medical device, and operates under an ISO 13485:2016 certified quality management system and US FDA Quality Management System Regulation (QMSR). Limbic has also been the subject of multiple peer-reviewed clinical studies published in journals such as Nature Medicine and The British Medical Journal.

With offices across New York, Georgia, and London, and backed by investors that include Khosla Ventures, Limbic partners with health plans and large health systems to scale mental health outcomes.