Clinical Operations Journal by Dx Direct

Dx Direct

FDA Approved vs. FDA Cleared: Understanding the Key Difference You Need to Know

In recent years, advanced consumer technology has rapidly evolved to include health-monitoring features, from fitness trackers to wearable devices. As these products gain popularity, more and more tech companies are seeking FDA approval or clearance to market their devices. But here’s the catch: FDA approval and FDA clearance aren’t the same thing. Knowing the difference can be crucial to understanding the safety and effectiveness of the devices you’re using. Let’s break it down. What Does the FDA Do? The Food and Drug Administration (FDA) is responsible for ensuring that foods, drugs, and

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Simplifying Point-of-Care Adoption

Supporting better decisions without adding complexity.

FebriDx is intended to support clinical decision-making and must be interpreted in the context of signs, symptoms, patient history, and clinical judgment. It does not identify a specific pathogen and is not a standalone diagnostic.

FebriDx® is manufactured by Lumos Diagnostics. Dx Direct serves as an authorized distribution channel and does not manufacture the product.

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