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FDA names second participant in TEMPO digital health pilot

Published

17 August 2026

Topic

opportunities

◆ Sectors

Digital Health

◆ Geography

United States

◆ Source

Read at medtechdive.com →

◆ Verified

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.

◆ Coverage

2 sources · 17 Aug 2026

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◆ Topics

Digital HealthFDAdigital-healthpilot-programreal-world-datamedicare