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FDA names second participant in TEMPO digital health pilot
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Fusion42 · 17 August 2026 · Fusion42 review
The FDA has added Cadence, an AI-enabled hypertension management software company, as the second participant in its TEMPO digital health pilot, allowing participants to collect real-world data through Medicare.
This Wire brief sits within Fusion42's coverage of Digital Health, and 2 sources have reported it.
◆ ◆ The Wire takeaway
You can now access new US real-world data routes through Medicare by joining FDA digital health pilots like TEMPO. This changes how you validate and scale AI health software under regulatory oversight.
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2 sources · 17 Aug 2026
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