FDA accepts Cadence and Limbic AI medical devices into TEMPO pilot for pre-authorization release

The Food and Drug Administration has accepted four devices, including artificial intelligence products from Cadence and Limbic, into its TEMPO pilot program. This initiative allows digital health companies to provisionally launch generative AI medical devices without formal marketing authorization. The pilot aims to support the Medicare ACCESS model, which funds technologies helping beneficiaries manage chronic conditions, while giving regulators real-world experience in AI regulation.

FDA TEMPO pilot program

• ▪The Food and Drug Administration accepted four devices, including artificial intelligence products from Cadence and Limbic, into its TEMPO pilot program.
• ▪The Food and Drug Administration's TEMPO pilot program offers the Food and Drug Administration and digital health companies an opportunity to experiment with artificial intelligence regulation in real-world settings.

Medicare ACCESS model integration

• ▪The Food and Drug Administration's TEMPO pilot program is intended to increase the number of technologies available for the Medicare ACCESS model.
• ▪The Medicare ACCESS model is an experimental program designed to pay for technology that helps beneficiaries manage chronic health conditions.

Pre-authorization product release

• ▪The Food and Drug Administration is provisionally allowing some developers of generative artificial intelligence medical devices to launch their products on the market without marketing authorization.
• ▪The Food and Drug Administration's TEMPO pilot program allows accepted digital health companies to release their products to patients before receiving formal marketing authorization.

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