The FDA has selected the first four companies to participate in its pilot program for digital health devices tied to chronic disease care.
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.
A breakdown of each company and the devices they’re testing:
- 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.
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.
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, which launched in July, aims to increase access to technology-supported care for Medicare patients managing chronic conditions.
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.
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