Hasta La Gadget!

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

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Via: Bloomberg

Source: FDA

Let’s just say for the sake of this story, you saved up and purchased both the PlayStation 4 and Xbox One during their respective launches. That probably made a serious dent in your finances, which probably means you weren’t able to get everything you want, like all of their launch titles. If you own a PlayStation 4 and Xbox One and have just been starting at it hoping for friends or family to buy you some games this holiday season, you can take matters into your own hands as Amazon has dropped the price of next-gen games down to around $49 for several games on both platforms. (more…)

PS4, Xbox One Games Discounted At Amazon To $49 original content from Ubergizmo.

Nikon ambassador Chris McLennan and engineer Carl Hansen have created a small remote controlled four-wheel drive rover to roam the savanna and capture photos of curious lions, like the cute pride above. It’s pretty neat. Watch it in action here.

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We’re sure by now, you already have chosen your instant messaging application and have been happy with its service for several months. Jumping to a completely new messaging service is a pretty hard decision, especially if those who you chat with don’t use the service you’re attempting to make the jump to. That doesn’t seem to be the case with Line, which has just announced they have passed the 300 million user milestone.  (more…)

Line Messaging App Surpasses 300 Million Registered Users Milestone original content from Ubergizmo.

Aging Busta Rhymes witticisms aside, this new Lenovo might just be a contender for anyone on the lookout for a versatile Windows 8.1 machine. The Flex 10 is a 10-inch version of the Flex 14 and 15 models we’ve already seen, with the same 1,366 x 768 resolution and 10-point touch panel, but with a Bay Trail Pentium or Celeron processor instead of Haswell. It’s a sort of half-way house between a fanless hybrid and a full-wattage laptop, and in some ways it offers the worst of both worlds — for example, the base model provides a battery life of just four hours but has a relatively stocky weight of 2.6 pounds (1.2kg). On the other hand, the Flex 10 should run Microsoft Office and other productivity software at a faster clip than mobile-class machines like the Miix 10 or Miix2. Plus, it allows the screen to be flipped back 300 degrees into a “stand” mode, likely without costing as much as a Core i3-powered Yoga 11S — assuming the unconfirmed starting price of $550 proves to be accurate. Lenovo has a habit of adding products to its website before releasing full pricing and availability, so we’ll update this post when we learn more. (Woo Hah!)

Filed under: Laptops, Lenovo

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Source: Lenovo