FDA-cleared data accuracy in consumer wearables: Increasingly important yet often overlooked

MedCity News September 15, 2022
John Mastrototaro

As consumers better understand their right to medical privacy, they will have higher expectations for wellness wearables that aren’t bound to data privacy regulations.

The wearable technology market is growing rapidly. With more than 30 percent of adults in the United States using the devices, the global market is set to exceed $380.5 billion by 2028. As the market evolves, wearables are expected to get more personal, powerful and stylish. And, we’re starting to see wearables transition from fitness to health devices. However, many device manufacturers are overlooking the most important aspect to consumers who want to use their devices for healthcare purposes: improved device accuracy and FDA clearance.

Wearable technology first appeared on the market in the early 2000s...

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