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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. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.

◆ 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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Topics

Digital HealthFDAdigital-healthpilot-programreal-world-datamedicare