Something’s not quite right about 23andMe’s DNA analysis kits, and the Food and Drug Administration is on it. The agency ordered 23andMe to stop selling the kits until the Google-backed company can prove that they actually work. Sounds reasonable.
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For more than five years, 23andMe has sent out personalized DNA test kits, offering consumers hundreds of clinical reports on their genetic risk for everything from diabetes to prostate cancer. Its mission to educate customers about their health and ancestry appears to have been dealt a blow, however, after the US Food and Drug Administration (FDA) said the company needs its approval. It’s told 23andMe to stop advertising its DNA-testing product until it gets the medical device classification it needs, which involves conducting studies of the kits to gain documented proof of their accuracy.
The agency is also worried that customers might take action, or not, based on test results that may or may not be correct. 23andMe has attempted to gain clearance in the past, but hasn’t done everything it needs to get the green light. Make no mistake, a run-in with the FDA is not to be taken lightly: satisfying the agency’s requirements is going to be a long and expensive process. 23andMe now has to tell the agency exactly how it intends to gain marketing authorization for the device, or it could face regulatory action (which includes injunctions, seizures and hefty fines).
Update: 23andMe has issued a statement on the matter:
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
Filed under: Internet
Via: Bloomberg
Source: FDA
According to studies, it has been found that epilepsy is the third most common neurological disorder in the US, but the good news to those who suffer from it, or know someone who suffers from it, is that the FDA has recently approved a skull implant that should help reduce the frequency of the seizures. This has been a long time coming, especially since the research began nearly a decade ago by NeuroPace, the company responsible for the manufacturing of the implant itself.
Seizures occur when groups of neurons fire off abnormally, but thanks to the implant, also known as the RNS Stimulator, it will be able to detect when these electrical signals are happening in the brain, and will be able to fire off impulses of its own which will help to regular brain activity. According to their research, this was tested with 256 patients to find out the implant’s benefits. Those with the implant enabled actually found a reduction of 37.9% in their seizures, and this reduced frequency was maintained even after two years later.
The RNS Stimulator was unanimously recommended by a panel of experts selected by the FDA and will see its implementation come February 2014.
FDA Approves Skull Implants To Help Treat Epilepsy original content from Ubergizmo. 
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Today, just over 100 years after the advent of trans fats, the FDA has announced that it’s taking the first steps toward banning them outright, removing them from the "Generally Recognized As Safe" list and out of the American food supply. It’s about time.
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Well that was quick. Seemingly hours after officials issued a health warning about a multi-state salmonella outbreak, the Centers for Disease Control (CDC) called nearly all of its food monitoring staff back in to work.
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Be careful what you put in your mouth: a public health alert has been issued by the US Food Safety and Inspection Service (FSIS) surrounding a massive salmonella outbreak. It comes on the back of the recent FDA closure because of the Government shutdown
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E-coli outbreaks crop up every now and then. Some are more widespread then others, but if they’re related to food and especially if that food may have crossed state lines, the FDA starts tracing to find the source. If foodborne bacteria cause an outbreak in the U.S. today, though, the FDA won’t do anything. Because the FDA is closed.
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App catalogs are flush with titles that allow users to play doctor, but according to the FDA, most of them are harmless and don’t warrant regulatory oversight. Instead, the agency has announced that it’ll take a more reactive, risk-based approach and will only require approval for mobile apps that “present a greater risk to patients if they do not work as intended.” Specifically, the FDA will scrutinize apps that perform the functions of regulated medical devices — such as an ECG monitor — along with those that are used as accessories to regulated medical equipment. As a telling statistic, only 100 mobile apps have received FDA clearance within the past decade, so imagine what would happen to the agency’s workload if it tried to exercise control over the Apple App Store and Google Play Store combined.
Filed under: Science, Software
Via: The New York Times
Source: FDA
As more and more Americans self-diagnose gluten sensitivities, the Food and Drug Administration has finally gotten around to enforcing some standards on what foods can carry a gluten-free label. Quite surprisingly, they don’t actually have to be free of gluten.
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Just because Billy is super hyperactive and can’t sit still doesn’t necessarily mean he has ADHD. But unfortunately, he might be identified as such. These kinds of medical mistakes could be avoided with a new brainwave-measuring cap that the FDA has just approved to help diagnose ADHD.
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