FDA

23andMe class action lawsuit claims misleading advertisements

23andMe class action lawsuit claims misleading advertisements

Taking a peek into our genes isn't something easily accomplished, and that is where the Google-backed 23andMe genetic testing service came in. For $99, anyone could send in their sample and receive the results a short while later. In recent days, the company was slapped with an order from the FDA to stop selling its kits, and a handful of days later, customers have filed a class-action lawsuit against the company.

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23andMe issues response following FDA warning and sales halt

23andMe issues response following FDA warning and sales halt

Earlier this week, the genetic testing company 23andMe was forced to stop selling its testing kit following an FDA decision that the kit is a medical device and requires regulatory approval. The decision was largely based on concern over inaccurate results, and led to a warning letter being published by the FDA. In response to the issue, 23andMe has published its own statement on the matter.

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Google-backed 23andMe genetic testing shuttered by FDA

Google-backed 23andMe genetic testing shuttered by FDA

DNA analysis company 23andMe has been forced to halt sales of its testing kit, after the FDA decided the saliva kit counted as a medical device and as such lacked the proper regulatory approval. The decision, which affects 23andMe's flagship "Personal Genome Service" (PGS) testing product, comes becomes the "FDA is concerned about the public health consequences of inaccurate results from the PGS device" the agency said in a warning letter, arguing that the company - which was co-founded by Anne Wojcicki, former partner of Google co-founder Sergey Brin - was putting customers' health at risk by potentially mis-diagnosing or overlooking actual medical concerns through its unapproved assessments.

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FDA approves iRobot RP-VITA for use in hospitals

FDA approves iRobot RP-VITA for use in hospitals

Last summer we mentioned that iRobot was conducting trials with the new telepresence robot called the RP-VITA. Today word has turned up that the FDA has approved that robot for use in hospitals within the United States. RP-VITA stands for Remote Presence Virtual Independent Telemedicine Assistant.

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FDA approves ‘ingestible sensor’ for use as a medical device

FDA approves ‘ingestible sensor’ for use as a medical device

Here's one that the conspiracy theorists among us will love: the FDA has approved an "ingestible sensor" made by Proteus Digital Health for marketing as a medical device. Though such a device sounds like it can't be anything other than devious, the idea behind it is quite simple, as it will be used to make sure that patients are taking their pills when they're supposed to. Apparently Proteus has been working with the FDA since 2008 to get this thing approved, so this could prove to be a pretty big breakthrough for the company.

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FDA says your body is a “drug” and subject to gov’t regulation

FDA says your body is a “drug” and subject to gov’t regulation

In what is perhaps one of the most controversial cases the Food and Drug Administration has ever participated in, there's a new argument that's making some pretty heavy waves. In essence, the FDA says that a person's individual body can be categorized as a "drug" and is thus subject to all the government-mandated regulations about interstate commerce and the like. That's the meta-level, theoretical interpretation so let's take a look at the specific case that has led to this wild claim.

 

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