FDA Deregulates Wellness Wearables: A Boost for Innovation and Consumer Health Tracking
By Michael Dorausch, D.C.
Chiropractors love measuring stuff, and recent FDA deregulation will open up a whole new world of opportunities in wellness and patient management.
In a move set to reshape the digital health landscape, the U.S. Food and Drug Administration (FDA) updated its “General Wellness: Policy for Low Risk Devices” guidance last week, effective January 6, 2026. This deregulation targets non-invasive wellness wearables and software, aligning with broader efforts to foster innovation in AI-driven health technologies. Devices that track everyday metrics such as sleep patterns, physical activity, heart rate variability, blood pressure estimates, oxygen saturation, and blood glucose trends are now largely exempt from stringent medical device regulations.
The implications of this change are far-reaching, promising to accelerate growth in the multibillion-dollar wellness wearables market. By reducing the need for premarket reviews and compliance hurdles, companies can now iterate on features more rapidly, integrating advanced AI for personalized insights into stress management, fitness optimization, and habit building.
Established industry leaders are primed to reap the rewards of this lighter regulatory touch. Apple’s Apple Watch, already a market frontrunner, can expand its suite of wellness features (like enhanced sleep and heart tracking) without additional FDA scrutiny. Google-owned Fitbit and Garmin are positioned to fast-track AI enhancements in their fitness trackers. Oura’s smart rings, specializing in recovery and sleep metrics, along with Whoop’s performance bands, now have clearer pathways for innovations such as blood pressure estimation. Even continuous glucose monitor (CGM) providers like Abbott, Dexcom, and Medtronic could pivot toward wellness-focused variants, offering nutritional trend insights outside medical contexts. This deregulation not only bolsters these giants but also lowers barriers for smaller players.
Looking ahead, the policy opens the door for a surge of new entrants and products in the wellness space. Oura is gearing up for enhanced ring models with advanced physiological tracking slated for 2026 launches. Expect a wave of AI-powered sensors, apps for nutrition and hormone monitoring, and non-invasive patches that blend seamlessly into daily life.
Talk to your patients about what they are wearing (I’m using fitbit) and how they are using the devices. We are going to see massive change in the wellness markets over the next few years.
