The US Food and Drug Administration has added AI products from Cadence and Limbic to its TEMPO pilot, letting the digital health companies release generative-AI clinical tools to patients before they receive full marketing authorisation.
A pre-authorisation runway for generative AI
The agency's Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot is designed to give the FDA hands-on experience with medical devices that lean on generative AI to make decisions about care. Devices accepted into TEMPO are allowed to reach patients ahead of a standard 510(k) or De Novo clearance, and the sponsor still has to complete a full regulatory submission if it eventually wants long-term market authorisation.
Four new participants
According to reporting from STAT on September 3, 2026, four generative-AI medical devices were selected in the latest tranche. Among them: Nashville-based Cadence, whose AI-driven remote care platform manages patients with hypertension, heart failure, COPD and type 2 diabetes; and London-based Limbic, whose clinician-supervised AI voice technology supports mental healthcare delivery inside the UK's NHS Talking Therapies programme.
Feeding the Medicare ACCESS model
TEMPO is intended in part to bulk up the pipeline of technologies eligible for the Medicare ACCESS model, a payment experiment that reimburses digital tools helping beneficiaries manage chronic conditions. Alongside Cadence and Limbic, the FDA earlier this year accepted a remote hypertension management platform and a chronic-disease self-management tool. The move continues a shift by CDRH toward flexible, real-world evaluation of high-risk AI, following programmes such as the predetermined change control plan framework for adaptive algorithms.
Reporting based on coverage from STAT News and FDA Digital Health Center of Excellence bulletins.