Wearable Wellness Devices Dominate CES as FDA Loosens Rules

The doctors will see you now — and around the clock, from now on. Every step you take, every move you make, they’ll be watching you.

At the Consumer Electronics Show (CES) this week, the tech industry unveiled a new wave of AI-fueled, health-centric wearable devices and technologies, just as the US Food and Drug Administration moved to blur the lines between wellness wearables and professional-grade medical devices. But is it all just what the doctor ordered?

No Worse for Wearables

Among the new wave of wearable tech unveiled at CES are a continuous glucose-monitoring device from SenSura, a new nutrition-tracking platform for Garmin’s smartwatches, and fancy new blood pressure-monitoring devices from Chinese startups such as Dreame Technology and J-Style. Up until recently, such devices may have been considered a step too far for consumer tech. Just last year, for instance, the FDA sent a letter to wellness wearable firm Whoop after it rolled out a feature to check users’ blood pressure. Per the FDA, measuring blood pressure amounts to a medical diagnosis, something for which the company did not receive regulatory authorization. In 2024, the agency warned consumers not to use smart watches and smart rings that promise to measure blood sugar levels without piercing the skin.

Now, the agency says, it will take a different posture:

• On Tuesday, in a video posted on X while attending the show, FDA Commissioner Marty Makary said the agency is hoping to “promote more innovation with AI in medical devices.” Under the new guidance, the agency is allowing “low-risk” wellness-focused wearables more leeway to track health metrics such as blood pressure and blood sugar levels.
• “In the past, the FDA has permitted some measurements like pulse rate and O2 saturation in some wellness products, but not others,” Makary said during a CES speech. “It didn’t always make a lot of sense from the outside.”

Dr. ChatGPT: Feeling loose, the FDA also eased rules this week for so-called “clinical decision support software,” tech that can help doctors make medical recommendations. For OpenAI, it was the right prescription. On Thursday, the preeminent AI firm unveiled a new HIPAA-compliant version of ChatGPT designed to help healthcare professionals with medical reasoning and other administrative tasks. So long, WebMD. Hello, Dr. ChatGPT.