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Digital Health › Medical Devices › Mobile Health Apps

Wilson Sonsini Goodrich & Rosati

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

Wilson Sonsini Goodrich & Rosati on

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

Butler Snow LLP on

Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Rivkin Radler LLP

FDA Announces Digital Health Center of Excellence

Rivkin Radler LLP on

On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more

Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...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

Kelley Drye & Warren LLP

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

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