News & Analysis as of

Digital Health Regulatory Oversight Wearable Technology

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Hogan Lovells

Digital Health: CE marking of medical devices

Hogan Lovells on

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

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