The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as TEMPO, allows digital health devices to be offered to Medicare patients before the agency has authorised them for that use.

The mechanism is enforcement discretion. Rather than granting approval, the FDA agrees not to enforce premarket authorisation requirements for participating devices, provided manufacturers collect and share real-world data on how those devices perform in practice.

What Dexcom is offering

The Dexcom Glucose Health Program will address two clinical use areas within the Centers for Medicare and Medicaid Services ACCESS model. It is intended to let patients and their clinicians monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for behavioural changes.

The FDA describes the programme as an aid in screening for prediabetes and type 2 diabetes through integrated digital health metrics, and says it may contribute to improving glycaemic control and lowering HbA1c in people with prediabetes. The agency notes it will continue to evaluate the intended use during the pilot.

“For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. She called the selection a milestone in generating “the real-world evidence needed to ensure these technologies truly deliver.”

The payment model underneath

TEMPO does not exist on its own. It operates in connection with ACCESS, a ten-year voluntary CMS payment model whose first cohort launched this month with more than 150 accepted healthcare organisations.

ACCESS introduces what CMS calls outcome-aligned payments, recurring payments tied to whether participating organisations achieve measurable health improvements rather than the volume of services they deliver. It targets chronic conditions affecting more than two-thirds of Medicare beneficiaries, including hypertension, diabetes, chronic musculoskeletal pain, and depression.

“ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly,” said Abe Sutton, CMS deputy administrator and director of the Innovation Center.

A side door, with conditions

Law firm Hogan Lovells characterised the arrangement in December as a CMS-linked side door, noting the pilot may permit commercial use and promotion of products that would ordinarily be prohibited under device regulations. Its analysis flagged several unresolved questions about the scope of oversight.

Patients are not left uninformed. ACCESS organisations that use a TEMPO device must obtain enhanced consent from beneficiaries, telling them the device is part of an FDA pilot and that certain data will be shared with the agency.

The FDA plans to select up to around ten participants in each of four ACCESS clinical use areas: early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal pain, and behavioural health. It says its considerations include the potential for serious risk to patient health, safety, or welfare.

The evidence question

The pilot rests on a bet that real-world data can substitute, at least partly, for the prospective trials the FDA has historically preferred in device reviews. Hogan Lovells noted that the use of real-world data to support device marketing applications has lagged, leaving the value of TEMPO-generated evidence uncertain.

The FDA has also cautioned that participation in TEMPO is not an indication of whether it will issue a positive decision on any future marketing submission. What happens to a device, or the patients using it, if the real-world data proves inconclusive remains unspecified.

A wider loosening

TEMPO arrives amid a broader shift in how the FDA approaches consumer and AI-enabled health technology. In January, the agency updated two guidance documents that loosened oversight of wearables and clinical decision support tools, meaning more AI-enabled health products can reach consumers without premarket review.

The commercial context is a market moving faster than the regulatory apparatus around it. Amazon opened its Health AI assistant to all US customers this year, joining OpenAI’s ChatGPT Health and Anthropic’s Claude for Healthcare in a rush to put AI-mediated health guidance in front of consumers.

Enterprise healthcare is moving too. Bunkerhill Health raised $55 million to let hospitals build and run their own clinical AI agents rather than buying fragmented vendor tools, and Microsoft launched Copilot Health to push AI into consumer health queries at scale.

Chronic disease is the pressure point driving all of it. The WHO expects chronic conditions to account for 70% of global deaths by 2030, up from 61% in 2005, a trajectory that makes preventative and continuous monitoring technologies commercially and clinically urgent.

There is no deadline for manufacturers to submit statements of interest to TEMPO. The FDA says it will continue sending follow-up requests to potential participants indefinitely.

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