Wellness Wearables Surge: FDA Modifies Regulation in Significant Policy Shift
In a landmark move for the health and wellness industry, the U.S. Food and Drug Administration declared on January 6, 2026, its decision to scale back regulation of wearable devices and software aimed at promoting healthy lifestyles. This announcement came with new guidance to elucidate its regulatory approach.
This policy shift is anticipated to fuel innovation in the wellness technology sector, a field currently witnessing exponential growth. Industry experts predict that technological wearables monitoring sleep, exercise, and blood oxygen levels will see a surge in popularity in 2026.
Major industry players like the Finnish company Oura (valued at $1 billion in 2025) and subscription-based Whoop (valued at $3.6 billion in 2021) are set to demonstrate remarkable adoption rates.
“We’re now moving beyond passive observation. We’re not just looking at the data, we’re making new habits based on it,” said Olivia Houghton, head of beauty and wellness at consultancy the Future Laboratory.
Research indicates that an average of two new healthy behaviors are being formed based on these devices, with a whopping 87% of users reporting changes such as:
- Improved sleep habits
- Increased exercise frequency
The FDA’s decision to limit stringent regulation represents a significant boost for the wellness wearables market, potentially hastening consumer access to innovative health tracking technologies.
Source: Business of Fashion