The Food and Drug Administration expanded its digital health pilot program by including Cadence, a company that develops artificial intelligence-assisted software for hypertension management.
This decision permits Cadence to gather real-world data through Medicare without undergoing the FDA’s usual premarket authorization process. The initiative, named Technology-Enabled Meaningful Patient Outcomes (TEMPO), evaluates how digital health tools perform outside controlled clinical environments.
Software designed for medication management
Cadence created HypertensionOS, a prescription tool that assists clinicians in managing medication for patients with Stage 2 hypertension. The software automates routine steps in medication initiation and titration while adhering to safety parameters established by healthcare providers.
It is not intended for patients with heart failure, pregnancy, active cancer, or end-stage renal disease on dialysis. Cadence stated that the system operates within clinician-defined limits, supporting rather than replacing their decision-making.
“Clinical AI should extend the judgment and reach of clinicians by safely handling routine care within the boundaries they set,” said Cadence CEO Chris Altchek. “Our selection for TEMPO lets us help build the evidence, safeguards, and operating model needed to bring this approach to millions with chronic conditions.”
Real-world data could shape future regulations
Cadence will submit data on the software’s safety, performance, and patient outcomes to the FDA. The findings may influence how clinical AI systems are developed and regulated moving forward.
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A retrospective study of the software involving over 23,000 participants showed an average blood pressure reduction of 7/5 mm Hg after 30 weeks. While encouraging, these results require validation in broader, real-world settings through the TEMPO program.
Digital health tools often face challenges proving their effectiveness in everyday care, where factors like patient behavior and provider workflows differ from clinical trials. TEMPO aims to address this by allowing devices to generate evidence during routine use.
The FDA’s pilot aligns with a separate effort by the Centers for Medicare and Medicaid Services (CMS), which promotes digital technologies for chronic condition management. Providers in the CMS model can offer TEMPO-approved devices to patients, potentially speeding up adoption.
Last month, diabetes technology firm Dexcom became the first participant in the program. The FDA intends to include up to 10 manufacturers in each of CMS’ four focus areas: early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health.
Cadence’s inclusion represents another step toward integrating AI-driven tools into chronic disease management. The outcome may set important precedents for how these technologies are assessed and implemented.
