fda

So the FDA spied on scientists' e-mails? Surprised?

Being a boss can lead to a paranoid life.

You think you know who's on your side. But do you? After all, in order to become a boss, you did have to betray a couple of people along the way. How can you tell who's doing it to you?

Thankfully, technology has offered you more than one easy option.

Today's revelations in the New York Times that the FDA spied on its scientists' e-mails offers a picture of large-scale prying into not merely work correspondence but personal matters too.

The Times' discovery shows a systematic level of … Read more

Massage device recalled after strangling user

Let's all be thankful that the pictured woman enjoying her Shoulderflex isn't wearing a necklace or much in the way of clothing, and also that her hair is tied neatly atop her head. It turns out that necklaces, clothing, and hair have the potential to turn that peaceful look on her face into something else entirely.

No, seriously. One person was strangled to death after her necklace became caught in the personal massager's rotating component, while another was almost killed when a piece of clothing was caught. Still more have been injured when their hair became entangled in the device.

In light of the death and injuries, the Food and Drug Administration issued a warning last week that the device posed serious health risks, and yesterday the manufacturer, King International, voluntarily recalled nearly all of its 12,000 Shoulderflex massagers in the U.S. sold between 2003 and 2011.

To be fair, the promotional demonstration of the massager advises users to keep hair and jewelry away from the rotating bar--an obvious caution reminiscent of the floor being slippery when wet.

The video did not, however, warn that failure to do so could result in death by strangulation. (The video appears to have been deleted from a variety of sources as the Beaverton, Ore.-based firm tries to extricate itself from the unraveling imbroglio. Calls to the company for comment, meanwhile, went straight to voice mail.)

If you've got a Shoulderflex on hand, the FDA implores you to throw it away.… Read more

Will the FDA regulate social media? (Q&A)

ASPEN, Colo.--The U.S. Food and Drug Administration started to discuss possible Internet regulations at an event it convened in 1996. Fifteen years later, the pharmaceutical industry is still waiting for an outcome.

A blog post from the Public Relations Society of America last week complained that "it's time for the FDA to act and to properly advise" pharmaceutical manufacturers about what kind of advertising is and isn't allowed, especially on social-networking sites. PhRMA, a trade association representing pharmaceutical makers, said this month that "we continue to wait for FDA's guidance, and to … Read more

FDA seeking to regulate mobile medical apps

The Food and Drug Administration is looking for input on a new proposal that would let it regulate certain medical apps that run on mobile devices.

Noting that today's crop of mobile medical apps can perform a variety of tasks, from counting calories to helping people monitor their weight to letting doctors view patient scans, the agency wants to ensure that such apps are safe.

"The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a … Read more

Biochemist says 'naked' X-ray scanner may be unsafe

A University of California at San Francisco professor of biochemistry told CNET today that the Obama administration's claim that full-body scanners pose no health risks to air travelers is in "error."

The administration's defense of the controversial machines, which use X-rays to perform what critics have dubbed naked strip searches, has "many misconceptions, and we will write a careful answer pointing out their errors," said John Sedat, a UCSF professor of biochemistry and biophysics and member of the National Academy of Sciences.

"Because four people are working on this, it will not be … Read more

FDA tests internal cloud for disaster recovery

The U.S. Food and Drug Administration is looking at using an internal (or private) cloud to manage disaster recovery.

In early testing, Joe Klosky, a senior tech adviser at the FDA, was able to successfully restart applications and services within 45 minutes onto other, differently configured servers in their environment without issues using Cassatt Active Response, not people or outsourced services.

Klosky notes:

"An internal cloud approach means that we do not have to pay for costly service contracts with outsourcers, nor do we have to dedicate rooms full of servers to sit idly by just in case … Read more

Intel's in-home health device gets FDA nod

The new Intel Health Guide--which collects vital signs and allows for remote interactions between patient and doctor--may soon make its way into the homes of consumers with chronic health conditions such as diabetes and congestive heart failure.

The Food and Drug Administration approved the medical device, Intel announced Thursday.

The 8-pound in-home gadget connects caregivers and patients outside of hospitals or clinic settings. It manages vital-sign collection, patient reminders, educational content, and motivational messages. The device has a 40GB hard drive.

Information collected by the device is sent to the health care professional, and from there, physician and patient … Read more