The FDA has selected Cadence’s HypertensionOS as the second digital health participant in the TEMPO pilot, run with CMS’s ACCESS Model. HypertensionOS is a SaMD that supports clinician-supervised medication initiation and titration for stage 2 hypertension using AI-assisted features and deterministic safety checks. The tool is available only within TEMPO, is not FDA approval, and excludes several high-risk patient groups. Cadence will collect real-world safety, performance and outcome data to help shape future clinical AI regulation.
FDA Taps Cadence’s HypertensionOS for TEMPO Pilot to Evaluate Clinical AI in Hypertension Care
HypertensionOS is designed for clinician-supervised medication management in patients with stage 2 hypertension. Credit: PeopleImages / Shutterstock.com.
The U.S. Food and Drug Administration (FDA) has selected Cadence’s HypertensionOS as the second digital health software to participate in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, run in collaboration with the Centers for Medicare & Medicaid Services (CMS) Innovation Center under the ACCESS Model.
What HypertensionOS Is
HypertensionOS is a software-as-a-medical-device (SaMD) designed to support clinician-supervised medication management for patients diagnosed with stage 2 hypertension. The tool combines protocol-driven workflows with AI-assisted features to help licensed clinicians—such as physicians and advanced practice registered nurses—initiate and titrate antihypertensive medications in outpatient care.
How It Works
The system operates within predefined eligibility criteria and deterministic safety checks. It provides protocol-bound decision support rather than autonomous clinical decision-making: clinicians retain oversight and make the final treatment decisions. Continued use is permitted if a patient’s hypertension stage improves from stage 2 to stage 1 during management.
Safety, Limitations and Exclusions
HypertensionOS is explicitly not intended for certain high-risk patient groups, including those with heart failure, end-stage renal disease on dialysis, pregnancy, active cancer, or other specified comorbidities. The software is currently available only within the TEMPO pilot and its participation does not represent FDA approval or clearance.
Cadence founder and CEO Chris Altchek: "Chronic care cannot scale by asking clinicians to do more manual work. The opportunity for clinical AI is to extend the judgment and reach of clinicians by safely carrying out routine care within the boundaries they define."
Why TEMPO Matters
TEMPO seeks to expand access to selected digital health technologies while prioritizing patient safety and generating real-world evidence on their performance in routine clinical settings. Through its participation, Cadence plans to collect and report data on HypertensionOS’s safety, performance, and patient outcomes—information intended to inform future development and regulatory approaches for clinical AI systems.
Important note: The FDA has not made determinations regarding HypertensionOS’s safety or effectiveness for the uses under evaluation through TEMPO.
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