Limbic selected to FDA pilot, will test voice AI therapy with Medicare enrollees

The Food and Drug Administration (FDA) has chosen Limbic, a company that develops AI-led behavioral health tools, to participate in its TEMPO pilot. This pilot allows the agency to include devices that have not yet received FDA clearance in the new chronic care Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model.

Limbic is the first company in the cohort to use an AI-led mental health solution. Their new offering, Unpacked, utilizes a voice AI agent to deliver 20-minute cognitive behavioral therapy (CBT) sessions through scheduled phone conversations, with clinician oversight. Eligible participants are Medicare beneficiaries with clinically significant depression or anxiety who are enrolled in ACCESS.

Through TEMPO, Limbic will collect real-world data on outcomes, safety, and patient usage, which will assist in eventual FDA authorization if they decide to seek it. This participation offers Limbic the opportunity to reach an extensive patient base of 34 million Medicare beneficiaries. Ross Harper, co-founder and CEO of Limbic, explained that existing regulatory frameworks were not designed for generative AI in healthcare, so the FDA is partnering with selected companies like Limbic to apply enforcement discretion and ensure responsible and safe progress.

Unpacked is clinically a service, meaning a clinician remains responsible for each patient, reviewing progress, session content, and receiving real-time safety alerts. The AI-led approach aims to expand clinician bandwidth and scale care. Harper emphasized that the voice AI agent increases accessibility, as Limbic can reach patients with landline phones or flip phones, addressing the exclusionary nature of many digital health products.

Limbic is also waiving copays for ACCESS Medicare participants. The company's success can be attributed to their innovative approach to scaling services using new technologies, which aligns with the low rates of the CMS ACCESS program. A recent Limbic study found that CBT delivered via voice agents compared to text yielded gains in therapeutic alliance.

The default voice AI agent is female, though users can choose their preferred gender, and the company prioritized a voice that is compassionate, engaging, and understandable. Limbic has been deployed in 12 U.S. states and the U.K., supporting 850,000 patients, with many of them being Medicare enrollees. This decision to join ACCESS was influenced by the fact that seniors are under-represented among therapy recipients.

To participate in ACCESS, Limbic set up its own medical group to become a licensed Medicare provider and employs clinicians to maintain full care governance for patients.