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FDA names second participant in TEMPO digital health pilot

Published

17 August 2026

Topic

regulatory

◆ Sectors

Digital Health

◆ Geography

United States

◆ Source

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◆ Verified

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.

◆ Coverage

2 sources · 17 Aug 2026

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◆ Topics

Digital Healthfdadigital-healthclinical-airegulatory-pilotmedicare