Wire · regulatory
FDA names second participant in TEMPO digital health pilot
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Fusion42 · 17 August 2026 · Fusion42 review
The FDA selected Cadence as the second participant in its TEMPO digital health pilot, which exempts certain digital health devices from premarket authorization while collecting real-world data tied to a Medicare program to inform future regulation of clinical AI systems.
This Wire brief sits within Fusion42's coverage of Digital Health, and 2 sources have reported it.
◆ ◆ The Wire takeaway
You now have a government-backed route to test and validate AI health software without full FDA clearance, opening a pathway to scale chronic disease tools in Medicare settings.
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2 sources · 17 Aug 2026
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