Artificial Intelligence & Machine Learning,
Healthcare,
Industry Specific
Four Manufacturers Will Test Tools for Diabetes, Hypertension, and Mental Health
U.S. healthcare regulators are currently allowing health devices that incorporate advanced technologies, such as generative artificial intelligence, to be made available to patients suffering from chronic conditions even before receiving formal authorization. This milestone marks a significant shift in how healthcare devices may be deployed in real-world applications.
The Food and Drug Administration (FDA) has recently selected four device manufacturers to participate in the Technology-Enabled Meaningful Patient Outcomes, commonly referred to as the TEMPO pilot program. This initiative aims to provide services that feature cutting-edge capabilities, including AI-driven voice therapy and AI-assisted management of blood pressure medications.
As regulators navigate the complexities of overseeing medical devices that leverage generative AI technologies, this pilot program is designed to expedite the process of introducing new health technologies to patients, all while accumulating valuable real-world performance data. The objective is to ensure that these advanced technologies can contribute meaningfully to patient care without compromising safety.
“This is a promising opportunity that serves as a sandbox for digital technologies, allowing them to reach the market more quickly while also meeting explicit metrics for patient outcomes,” stated Shannon Lantzy, president of Medtech Throughput Labs, a consultancy specializing in medical device regulations. Lantzy emphasized that although the FDA would exercise enforcement discretion during this phase, caution is paramount; it will not permit untested or unsafe devices to enter the market.
According to Lantzy, “The same cybersecurity requirements that apply to product developers and health system operations will still be in effect.” This statement underscores the regulatory focus on maintaining high standards of safety and efficacy, even as innovative technologies are integrated into healthcare systems.
The TEMPO pilot program officially launched in December 2025, aiming to enhance access to digital health devices that cater to a range of conditions, including prediabetes, back strain, and depression. In exchange for improved patient care, participating organizations will provide the FDA with usage data that will facilitate the assessment of these devices’ effectiveness.
Participation in this program is extended to entities that are involved in a 10-year national Medicare and Medicaid payment model known as the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS). This model offers healthcare organizations recurring payments based on improvements in patient health outcomes, moving away from the traditional fee-for-service reimbursement model.
Abe Sutton, director for the Center for Medicare and Medicaid Innovation, articulated the implications of this groundbreaking payment structure. He noted, “Participating organizations will face financial risks if they fail to achieve better health outcomes.” Sutton, in a podcast with the American Medical Association, emphasized the initiative’s goal: to leverage technology within the healthcare system effectively while controlling costs. “Our aim is to ensure that we are not continually paying more for new solutions, but rather rewarding achievement in health outcomes,” he remarked. “Utilize any tools necessary to reach those goals.”
The TEMPO program is designed to facilitate the kind of tech-driven care advocated by the ACCESS payment model. Moving forward, the FDA intends to involve an additional six manufacturers, having already selected four within a two-month span. Among the pioneering participants is Dexcom, a glucose biosensing company whose Glucose Health Program aims to provide real-time data and AI analyses to patients and their caregivers regarding nutrition intake and screening for prediabetes and Type 2 diabetes.
In addition, Cadence, a clinical AI company, has developed HypertensionOS to assist authorized healthcare professionals in prescribing and modifying blood pressure medications for patients diagnosed with Stage 2 hypertension. Another innovative entrant is Limbic, a mental health AI provider whose Unpacked program utilizes an AI-powered voice agent to deliver structured cognitive behavioral therapy to adults experiencing depression or anxiety, all while ensuring clinical oversight. Lastly, SonderMind’s Adjunctive Care Application, a smartphone app, has been developed to help alleviate symptoms of both depression and anxiety as an adjunct to psychotherapy or medication.
The FDA expects that the participating manufacturers will ultimately seek marketing authorization for their products by leveraging the real-world data accumulated throughout the pilot. This evolution in regulatory practices reflects a growing recognition of the potential for technology to revolutionize healthcare, enabling patient-centric solutions that promise improved outcomes across various chronic conditions.