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The pharma implications of the FDA’s policy on low risk devices

fda

On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it. The document, which you can download here, relates to the FDA’s policy on what it deems as “low risk devices,” i.e., wearables.

Low risk devices, by the FDA’s definition, are those that, “involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions.” And, more specifically, a general wellness device has,

1)  intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and,

2)  intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.

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Can technology help you lose weight?

Groan

I’m fat.

This is not a new revelation, nor one that I’m just coming to realize, but it needs to be written none the less. I’ve had an up and down battle with my weight for about 15 years now and given that I’m about to turn 42, it’s high time to do something about it.

It wasn’t always this way for me as I’ve always been active and athletic. I made the varsity swim team in 7th grade and at the time (which may still be the case), I was the only student to graduate having lettered 6 times in the same sport. I made my division 2 lacrosse team as a walk on in college. When I transferred to art school I was an avid mountain biker and would often ride the 15 or so miles up or around Mohonk mountain from my apartment in Rosendale NY to my college in New Paltz. I was lean and fit. I could eat anything I wanted and I couldn’t possibly tell you how much I weighed. It never mattered.

Then I graduated, moved to NYC, and my life became more sedentary. I went to the gym 3 days a week (off and on) but slowly gained weight. the problem I later realized, was that I never learned how to eat correctly. I would eat healthy foods, but most always too much. My eating habits were formed by that 18-28 year old guy who burned enormous calories riding his bike, but my eating patterns maintained even after the exercise routines waned. The problem only got worse after I got married and kids came along, as I had almost no time to work out.

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Friday Follow Ups

Smoking Will Kill You

The Robotification of Society is Coming – Just wait until they figure out how democracy works

23andMe strikes deals with big pharma – I’m shocked, SHOCKED, that a company would blatantly sell your data like this </sarcasm>

Technology Has Made Life Different, but Not Necessarily More Stressful – I find the real stress comes from the higher magnitude of people asking how to use their devices. It’s called Google people.

Augmedix raises $16M for Google Glass clinical documentationOops!

Fairview Health invests in Zipnosis for asynchronous telemedicine – Nothing like showing your product demo on a device that doesn’t exist.

Google to stop selling Glass

From the Wall Street Journal

Google Inc. is making big changes to its troubled Glass wearable-computing project, giving a former Apple Inc. executive oversight of the initiative as the Internet giant grapples with the best way to expand from its software roots into hardware.

I’ve long been unimpressed with Google’s hardware chops and this may be a step in the right direction, but the Glass project has been a boondoggle from the start. I used them for several weeks and found them to be a complete mess. Having the Nest guys work on it could be a good start, or this may be a very quiet way of killing the product.

Google will stop selling the initial version of Glass to individuals through its Explorer program after Jan. 19. Google will still sell Glass to companies and developers for work applications.

Google plans to release a new version of Glass in 2015, but it hasn’t been more specific about timing.

Google being nascent with details about something in a press release? Shocking.