Four companies, four chronic-disease bets
The Food and Drug Administration has added two behavioral health companies, London-based Limbic and Denver-based SonderMind, to its TEMPO for Digital Health Devices Pilot. The addition brings the pilot to four participating manufacturers, according to the FDA's own participant list (FDA, 2026).
The other two are diabetes technology firm Dexcom, named the pilot's first participant on July 22, and hypertension software maker Cadence, added in mid-August (FDA, 2026; MedTech Dive, 2026). Limbic and SonderMind followed on August 19 and August 24 (Businesswire, 2026; MedTech Dive, 2026).
TEMPO, short for Technology-Enabled Meaningful Patient Outcomes, is a joint effort between the FDA and the Center for Medicare and Medicaid Innovation's ACCESS model, a Medicare payment structure that pays providers for improving outcomes in chronic disease management (FDA, 2026). The FDA announced the pilot on December 5, 2025, and began accepting statements of interest from manufacturers on January 2, 2026 (Duane Morris, 2026). The agency has said it plans to select as many as 40 manufacturers in total, up to 10 in each of four clinical-use areas: early cardio-kidney-metabolic conditions, established cardio-kidney-metabolic conditions, musculoskeletal pain, and behavioral health (Duane Morris, 2026).
What each product does, as the companies describe it
Dexcom's entry is an AI-powered glucose health program that combines data from its G7 and Stelo sensors with information on nutrition, activity, sleep and stress to generate what the company calls personalized insights for clinicians and patients (Dexcom, 2026).
Cadence's product, HypertensionOS, is prescription software that the company describes as incorporating AI-assisted functionality to support clinician-supervised medication management for patients with Stage 2 hypertension (Businesswire, 2026).
Limbic's product, called Unpacked, is described by the company as a clinician-supervised service that delivers cognitive behavioral therapy to Medicare beneficiaries with clinically significant depression or anxiety through scheduled phone conversations with an AI voice agent (Fierce Healthcare, 2026). Limbic says a licensed clinician reviews each patient's session content and progress, receives real-time safety alerts, and can adjust or take over a patient's care at any point (Fierce Healthcare, 2026). The company says the service began enrolling patients on August 27.
SonderMind's entry, the SonderMind Adjunctive Care Application, is a smartphone app the company describes as intended to help reduce anxiety and depression symptoms in adults as an adjunct to therapy or medication (MedTech Dive, 2026). SonderMind states the app is contraindicated for patients experiencing suicidality, manic episodes, psychosis or PTSD (MedTech Dive, 2026).
None of these clinical descriptions are independently verified in this report. They are stated here as the companies describe their own products.
What TEMPO actually permits
The regulatory mechanism is what makes this notable. A manufacturer accepted into TEMPO can ask the FDA to exercise enforcement discretion on certain requirements, including premarket authorization and Investigational Device Exemption rules, while it offers the device to patients covered under the ACCESS model (Nixon Law Group, 2026). In exchange, the manufacturer commits to collecting and reporting real-world data on safety and performance, with a stated intent to eventually pursue standard marketing authorization (Nixon Law Group, 2026).
That means the FDA has not yet evaluated the effectiveness of Unpacked or the SonderMind app for the specific uses under which they are operating inside the pilot, a point MedTech Dive's coverage states directly (MedTech Dive, 2026). STAT News reported on the pilot on September 3 and described TEMPO as a way for the FDA to gain real-world experience with devices built on generative AI before it settles on how to regulate that category. The same arrangement gives developers a route to patients ahead of full marketing authorization (STAT News, 2026).
What patients and clinicians should know
Access to these products runs through the ACCESS model, so they are reaching a defined population: Medicare beneficiaries whose care falls under that payment structure, not the general public (FDA, 2026). Clinician oversight is a condition each company has built into its pilot design, not an optional feature layered on top. Limbic states that a licensed clinician supervises every patient from intake through discharge (Fierce Healthcare, 2026).
Neither the Unpacked service nor the SonderMind app carries a standard FDA clearance for its use in this pilot. Their regulatory status is provisional, tied to continued data collection, and can be withdrawn if the reported safety or performance data raise concerns (Nixon Law Group, 2026). Manufacturers are required to report safety findings to the FDA throughout participation (Nixon Law Group, 2026).
What happens next
The FDA has said it intends to keep adding manufacturers to TEMPO on a rolling basis as it works toward its roughly 40-participant target across the four clinical areas (Duane Morris, 2026). Separately, the agency has an open public comment process on how it should regulate generative AI-enabled medical devices more broadly, running alongside the pilot rather than as part of it (FDA, 2026).
The next milestone to watch is not another company announcement but data: how the real-world performance and safety information Limbic and SonderMind are required to submit compares with what each company claims about its product, and whether that record supports a standard marketing authorization when the companies eventually seek one.