US FDA to limit regulation of health and fitness wearables, commissioner says

[BumRushDaShow]

Source: msn/Reuters

12h


Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.

The guidance, along with comments from FDA Commissioner Marty Makary, adds to existing policy that classifies low-risk wellness tools, such as fitness apps and activity trackers that encourage exercise, as non-medical devices exempt from stringent regulation, provided they do not make claims related to disease diagnosis or treatment.

"We have to promote these products and at the same time, just guard against major safety concerns," Makary said in an interview with Fox Business about artificial intelligence software such as ChatGPT, adding that "if people are looking up a symptom on an AI-based tool, let's have that conversation when they come in to see their doctor or do a virtual visit."

Shares of continuous glucose monitor manufacturers Abbott, Medtronic and Dexcom closed between 1% and 4% higher. U.S.-listed shares of fitness smartwatch maker Garmin ended nearly 3% higher.

Read more: https://www.msn.com/en-us/technology/software/us-fda-to-limit-regulation-of-health-and-fitness-wearables-commissioner-says/ar-AA1THOJi

[bucolic_frolic]

1. Gotta decorate the tattoo generations with some IT bling, lots of money to be made. /nt

[Probatim]

2. What does that mean?

I am well into my 50s, have no tattoos, and have been wearing a Garmin watch for about 10-11 years.

Not only does it track my running, cycling, and hiking activities, it measures my HR, pulse ox, sleep, and heart rate variability and a few other things. It's a great tool for checking in on yourself and a decent tool to share with my PCP when he asks what I've been up to.

It's a very good tool for monitoring overall health. I can see from the charts when I'm pushing myself too hard and when I can turn it up a bit. When I am under the weather, like I was in December, the data shows that I was sick (heart rate variability was well below my normal range).

Not sure where the hate for wearables comes from - in my experience, they are pretty good at keeping me motivated.

[bucolic_frolic]

6. My post was not an esthetic comment. It was following the lead of industry deregulation. /nt

[lonely bird]

3. Well

Sure, they can be sold. I don’t much care about that except if they make outrageous claims.

That being said “we” (the FDA) doesn’t have to promote them. Makary can go fuck himself.

[sboatcar]

4. So this means they'll be able to sell things like battery operated magic crystals

Woo medicine is striving to become mainstream, and the idiots in charge are welcoming them (and their large donations to their campaigns and nonprofits)

[BumRushDaShow]

5. Well there is now an "AI Lego"

called a "Smart Brick" -

[ananda]

7. I don't wear a thing...

and I'm doing just fine for my age.