The FDA has selected the first four companies to participate in its pilot program for digital health devices tied to chronic disease care, confirming a significant expansion of the FDA TEMPO digital device pilot since its initial launch.
How the FDA TEMPO Digital Device Pilot Program Began
In late July, Dexcom became the first participant in the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, also known as TEMPO. As of Aug. 21, three other companies have since signed on, expanding the pilot’s initial cohort to four total participants.
What Each Company Is Testing Within This FDA TEMPO Digital Device Pilot
SonderMind is creating a smartphone app meant to help adults 22 and older with moderate depression or anxiety, used alongside therapy or medication. Limbic is developing a product called Unpacked that uses an AI voice agent to deliver cognitive behavioral therapy to Medicare patients with significant depression or anxiety. Cadence Solutions’ HypertensionOS tool helps physicians and advanced practice registered nurses manage and adjust blood pressure medication for adult patients with Stage 2 hypertension. Dexcom’s Glucose Health Program pairs real-time glucose data with AI-driven insights to help screen for prediabetes and Type 2 diabetes and improve blood sugar control.
The Generative AI Question Within This FDA TEMPO Digital Device Pilot
Both Cadence Solutions’ and Limbic’s technologies use generative AI. The FDA does not currently have formal guidance for generative AI-backed devices. The agency said it will use its discretion on requirements such as premarket authorization as it reviews these devices through the pilot.
Why This Regulatory Discretion Matters
Applying agency discretion rather than established formal guidance means these two generative AI-based devices are essentially helping the FDA develop its regulatory approach to this technology category in real time, making their pilot participation as much about shaping future policy as about validating the specific tools themselves.
What Participation in This FDA TEMPO Digital Device Pilot Requires
Participating manufacturers must collect, monitor, and report real-world performance data on their devices’ intended uses. The devices are expected to be covered and used by patients participating in CMS’ ACCESS model, the payment model that launched in July aimed at increasing access to technology-supported care for Medicare patients managing chronic conditions.
Why This Connection to ACCESS Matters
Linking TEMPO pilot devices directly to CMS’s ACCESS payment model means participating companies aren’t just testing their technology’s clinical performance, but are simultaneously building the reimbursement pathway needed to sustain broader adoption once the pilot concludes, integrating regulatory and payment considerations from the outset.
The Planned Scale of This FDA TEMPO Digital Device Pilot
The FDA said it plans to select up to 40 TEMPO pilot participants total across four clinical use areas, including cardiometabolic risks, cardio-kidney-metabolic diseases, chronic pain, and behavioral health.
Why This Scope Suggests a Substantial Expansion Ahead
With only four companies selected so far against a target of up to 40, the current cohort represents just the earliest phase of a much larger planned pilot, suggesting significant additional company announcements and clinical use area coverage are still to come across the program’s four targeted disease categories.
What This FDA TEMPO Digital Device Pilot Means Going Forward
With generative AI-based tools from Cadence Solutions and Limbic already participating despite the absence of formal FDA guidance for this technology category, the pilot’s outcomes could directly inform how the agency eventually approaches regulating AI-driven digital health devices more broadly. Given the pilot’s direct connection to CMS’s ACCESS payment model, health systems and Medicare patients managing chronic conditions may begin seeing real-world deployment of these specific tools relatively quickly compared to devices navigating a purely traditional regulatory pathway.
What to Watch Going Forward
As the FDA continues selecting participants toward its target of up to 40 total companies, industry observers will likely watch which additional digital health companies join across the remaining clinical use areas, and how the agency’s regulatory discretion approach for generative AI devices evolves based on real-world data from Cadence Solutions and Limbic. Given the tight integration between this FDA TEMPO digital device pilot and CMS’s ACCESS model, the pilot’s progress may serve as an important indicator of how quickly AI-driven chronic disease management tools can move from regulatory pilot status into standard, reimbursed clinical practice.
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