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How can wearables be used in clinical trials? FDA outlines best practices
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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.
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2 sources · 21 Aug 2026
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