The US Food and Drug Administration (FDA) has selected Cadence’s HypertensionOS software as the second participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot for digital health devices.
HypertensionOS is a software as a medical device (SaMD) designed for clinician-supervised medication management in patients diagnosed with stage 2 hypertension.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The TEMPO pilot forms part of an FDA initiative, launched in cooperation with the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.
The programme aims to support access to specific digital health technologies while prioritising patient safety and collecting real-world evidence regarding their application in routine clinical practice.
HypertensionOS incorporates AI-assisted features to help licensed healthcare professionals, including physicians and Advanced Practice Registered Nurses, with medication initiation and titration workflows.
It operates within predefined eligibility conditions and deterministic safety checks, supporting protocol-bound decision-making in outpatient care for stage 2 hypertension.
Continued use is also permitted if a patient’s hypertension status decreases to stage 1 during management.
The device is not intended for patients with conditions such as heart failure, end-stage renal disease on dialysis, pregnancy, active cancer, or certain other comorbidities.
HypertensionOS is currently available only within the context of the TEMPO pilot, and its participation does not signify FDA approval or clearance.
The FDA has not made determinations regarding the product’s safety or effectiveness for the intended uses under evaluation through TEMPO.
Cadence founder and CEO Chris Altchek said: “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.
“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.”
Via participation in TEMPO, Cadence intends to collect and report data on the safety, performance, and patient outcomes related to HypertensionOS, which may help inform future approaches to developing and regulating clinical AI systems.
