Cadence, the clinical AI company automating the treatment of chronic disease, today announced its HypertensionOS software has been selected by the U.S. Food and Drug Administration as the second participant in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.

HypertensionOS is prescription software as a medical device (“SaMD”) that incorporates AI-assisted functionality to support clinician-supervised medication management for patients diagnosed with Stage 2 hypertension. Acting within predefined eligibility criteria and deterministic safety checks, the SaMD is designed to help carry out routine steps in medication initiation and titration. The device and its AI-assisted functionality is intended for use by licensed healthcare professionals with prescriptive authority, such as physicians or APRNs.

“Chronic care cannot scale by asking clinicians to do more manual work,” said Chris Altchek, Founder and CEO of Cadence. “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. Our selection for TEMPO gives us the opportunity to help establish the evidence, safeguards, and operating model needed to bring that vision to millions of people living with chronic disease.”

HypertensionOS is an important early step toward showing that bounded clinical AI, delivered within prescription software, can expand access to high-quality chronic care at national scale.

TEMPO was launched by the FDA in connection with the Centers for Medicare & Medicaid Services Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, and is intended to promote access to certain digital health technologies while safeguarding patient safety and generating real-world evidence on how they perform in everyday care.

Through TEMPO, Cadence plans to generate and report real-world data related to the safety, performance, and patient outcomes associated with HypertensionOS – evidence that will help inform how clinical AI systems are built, evaluated, and regulated going forward.

Cadence enters TEMPO with an established clinical and operational foundation. In partnership with more than 20 leading health systems, the company treats over 100,000 active patients with chronic disease. Peer-reviewed research shows Cadence drives a 70% relative increase in blood-pressure control among hypertension patients, alongside reductions in hospitalizations and total cost of care across chronic-disease populations.

With Cadence, patients are monitored daily, interventions happen sooner, and clinicians can focus their time on exceptions, uncertainty, and complex decisions. HypertensionOS is a meaningful milestone toward that future.

Regulatory Information

HypertensionOS is intended to support clinician-supervised, protocol-bound antihypertensive medication initiation and titration when predefined eligibility criteria and deterministic safety checks are satisfied. HypertensionOS is intended for use by licensed healthcare professionals with prescriptive authority, such as physicians or Advanced Practice Registered Nurses, to assist in the outpatient management of adult patients who, at the time of initiating HypertensionOS, have diagnosed Stage 2 hypertension. Patients who progress from Stage 2 hypertension to Stage 1 hypertension while being managed with HypertensionOS may continue to be managed with HypertensionOS. HypertensionOS is not intended for use by hypertensive patients with heart failure, end-stage renal disease on dialysis, pregnancy, active cancer, or certain other comorbidities.

HypertensionOS is only intended for use in connection with the TEMPO pilot at this time. Participation in the TEMPO pilot does not constitute FDA approval or clearance of HypertensionOS, or an FDA determination regarding its safety or effectiveness. The effectiveness of devices selected for TEMPO, for the intended uses being evaluated through the pilot, have not been evaluated by FDA.

About Cadence

Cadence is the clinical AI company automating the treatment of chronic disease. Its Clinical Intelligence takes on the routine, high-volume work of chronic care – monitoring patients, surfacing risks, and coordinating action – so clinicians can focus on the decisions that require them. Grounded in partnerships with more than 20 leading health systems, deep EMR integrations, dedicated medical group, and experience serving a population of more than 100,000 patients, the system learns from real-world care delivery, improving as it scales. Cadence has been recognized by TIME as one of the Top 100 HealthTech Companies and by LinkedIn as a Top Startup (#4, 2025). To learn more, visit www.cadence.care.

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