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How can wearables be used in clinical trials? FDA outlines best practices

Published

21 August 2026

Topic

opportunities

◆ Sectors

Healthtech Infrastructure

◆ Geography

United States

◆ Source

Read at yahoo.com →

◆ Verified

Fusion42 · 21 August 2026 · Fusion42 review

The FDA has outlined best practices for using wearables and digital health technologies in clinical trials, emphasizing the need for validation and patient-centred measures to ensure meaningful health insights. This guidance aligns with the FDA's broader focus on incorporating real-world evidence and patient-generated data in regulatory decision-making for medical devices.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure, and 2 sources have reported it.

◆ ◆ The Wire takeaway

You must build or integrate wearable tech validated for precise health measurements if you target US clinical trials, as FDA is raising the bar on patient-relevant data and evidence quality. This is your chance to enter a market where regulatory acceptance now demands rigorous proof of impact.

◆ Coverage

2 sources · 21 Aug 2026

◆ Related on Wire

◆ Topics

Healthtech Infrastructurefda-guidancewearablesclinical-trialsdigital-healthreal-world-evidence