FDA Adds Limbic AI Voice Therapy and SonderMind App to TEMPO Pilot

The U.S. Food and Drug Administration has added two behavioral health products to its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot for digital health devices, bringing the number of participants to four, MedTech Dive reported on August 24. The newcomers are Limbic's Unpacked, which uses an AI voice agent to deliver talk therapy, and SonderMind's smartphone app for depression and anxiety.

They join Dexcom's glucose health program, the pilot's first participant, announced July 22, and Cadence Solutions' HypertensionOS, according to the FDA's participant list, which the agency updated on August 21.

How the pilot works

Each TEMPO participant intends to offer its device for care expected to be covered by the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model run by the Centers for Medicare & Medicaid Services Innovation Center. For those uses, the FDA said it intends to exercise enforcement discretion over certain requirements, such as premarket authorization and investigational device requirements.

The agency stated that it has not yet evaluated the effectiveness of the selected devices for the uses being tested in the pilot. Participating manufacturers will collect, monitor and report real-world data on those uses, whether they offer the device themselves as ACCESS participants or another ACCESS organization does.

The two behavioral health devices

According to the FDA's table, Unpacked is intended to deliver structured, cognitive behavioral therapy-based treatment through an AI voice agent to Medicare beneficiaries with clinically significant depression or anxiety, within an outpatient behavioral health service. The FDA lists the aims as increasing access to structured psychological treatment, enabling measurement-based care and supporting clinical oversight through real-time safety flagging and outcome monitoring.

The FDA lists a long set of contraindications for Unpacked, including suicidal or homicidal ideation, moderate to severe dementia, psychotic disorders, eating disorders, pregnancy and substance use disorder as a primary condition. It also excludes people who do not speak or read English or who lack access to a telephone.

London-based Limbic said the service will start on August 27, with scheduled telephone conversations overseen by licensed clinicians who supervise each patient's care, according to a company announcement reported by Healthcare Innovation. "This is not AI replacing a therapist," said Patricia Taylor, a licensed clinical psychologist and head of clinical operations at Limbic. "Unpacked is a clinical service, and a clinician remains responsible for every patient."

SonderMind, based in Denver, will offer the SonderMind Adjunctive Care Application, which the FDA says is intended to reduce levels of depression and anxiety in adults 22 and older who are in treatment for moderate depression or anxiety, as an add-on to psychotherapy or medication. It is contraindicated for people with current suicidality, a current manic episode, psychosis or post-traumatic stress disorder, according to the FDA.

Both companies will be able to offer their devices through the ACCESS model, which pays participating providers based on improvements in patient outcomes, MedTech Dive reported.