Cadence’s HypertensionOS Joins FDA’s TEMPO Program

Cadence, a clinical AI company automated chronic disease treatment, revealed its HypertensionOS software was selected by the U.S. Food and Drug Administration (FDA) 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 uses AI-assisted functionality to support clinician-supervised medication initiation and titration for patients with Stage 2 hypertension. It operates within predefined eligibility criteria and safety checks and is intended for licensed prescribers, including physicians and APRNs.

The FDA launched TEMPO through CMS’s ACCESS Model to expand access to digital health technologies while monitoring safety and generating real-world evidence. Through the program, Cadence will collect data on HypertensionOS’s safety, performance, and patient outcomes.

Cadence currently partners with more than 20 health systems and manages over 100,000 active chronic-disease patients, with peer-reviewed research showing a 70% relative increase in blood-pressure control among hypertension patients.

“Chronic care cannot scale by asking clinicians to do more manual work,” said Chris Altchek, founder and CEO “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.”

Last month, Dexcom became the first company selected for the FDA’s TEMPO pilot. Participation lets the company implement an AI-powered glucose health program that merges data from its G7 and Stelo continuous glucose monitors (CGMs) and health information like nutrition, physical activity, sleep, and stress.