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If Inaccuracy Were Illegal, The Feds Would Have To Regulate Most Health Gadgets

on November 26, 2013

TechCrunch

I wore a calorie counter armband from BodyMedia that told me I was burning over 3,000 calories a day. If that were true, I would be emaciated enough to play Gollum in the next Lord Of The Rings sequel.

The accuracy of consumer health gadgets varies widely across the spectrum, yet this hasn’t stopped the FDA from suspending popular genetic testing company 23andMe over concerns about the quality of their diagnostics. 23andMe may be at fault, but so is a large part of the entire health tech industry.

The FDA is scared that 23andMe could cause a stampede of unnecessary and invasive medical procedures from consumers who get false readings on life-threatening abnormalities. Specifically, women who test positive for a gene associated with onset breast cancer, BRCA1, have been known to demand mastectomies against doctors’ advice, even though “false positives” are quite common.

23andMe advises their consumers to follow up…

View original post 947 more words

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