<![CDATA[Gizmodo: fda]]> http://tags.gizmodo.com/assets/base/img/thumbs140x140/gizmodo.com.png <![CDATA[Gizmodo: fda]]> http://gizmodo.com/tag/fda http://gizmodo.com/tag/fda <![CDATA[NeuroStar TMS Depression Therapy System First To Be Given FDA Approval]]> Last year, Neuronetics' NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system became the first device of its kind to be cleared by the FDA for treating depression. Although, the similarity to a dentist chair was probably not a great idea.

Nonetheless, trials on 164 patients with unipolar, non-psychotic major depressive disorder using the device proved that treatment with short magnetic field pulses to the left prefrontal cortex can be a viable alternative to medication. After 30 40-minute daily sessions, half of the patients in the trial experienced significant improvement, while a third reported complete resolution. Plus, the only statistically significant side effect was mild discomfort in the treatment area. Currently, patients can receive NeuroStar treatments in a psychiatrist's office while remaining completely awake and alert.

Given all of the uncertainty and danger surrounding many psychiatric drugs, NeuroStar seems like it's worth a shot for people suffering from serious bouts of depression. It could also be a sign of things to come. Perhaps technology like this will one day be implanted directly into our brains—making us feel awesome all the time. [NeuroStar and Medical News Today via PopSci]

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<![CDATA[FDA Deems E-Cigs As Bad As The Real Thing]]> Put down that e-cigar, Mark! The FDA has ruled that electronic cigarettes, cigars, and similar devices contain known carcinogens and slammed them for being marketed to younger age groups.

We've looked at what's inside e-cigars and our Mark Wilson has even tried them out, but what's the point of using a $200 gadget that's as unhealthy (or worse!) as the real thing?

The FDA's Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) came our with the following conclusions as a result of its analysis of e-smoking devices available on the market:

  • Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an ingredient used in antifreeze, is toxic to humans.
  • Certain tobacco-specific nitrosamines which are human carcinogens were detected in half of the samples tested.
  • Tobacco-specific impurities suspected of being harmful to humans-anabasine, myosmine, and β-nicotyrine-were detected in a majority of the samples tested.
  • The electronic cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine present in all cartridges tested, except one.
  • Three different electronic cigarette cartridges with the same label were tested and each cartridge emitted a markedly different amount of nicotine with each puff. The nicotine levels per puff ranged from 26.8 to 43.2 mcg nicotine/100 mL puff.
  • One high-nicotine cartridge delivered twice as much nicotine to users when the vapor from that electronic cigarette brand was inhaled than was delivered by a sample of the nicotine inhalation product (used as a control) approved by FDA for use as a smoking cessation aid.

Let's review: the device that's supposed to help you get healthier and save money by quitting smoking is more likely to worsen your addiction, be more harmful to your health, and be an even bigger waste of money. [FDA via Instead]

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<![CDATA[MedEx1000 Packs All Your Intensive Care Needs Into a Suitcase]]> The MedEx 1000, which just won approval by the FDA is a godsend for those of us who are doctors without borders, military medics or just really paranoid hypochondriacs. Dubbed the “ICU in a Suitcase,” this 40 pound machine fits in the trunk of your car and packs an electrocardiogram, blood pressure and oxygen monitoring, a ventilator, low and high rate infusion pumps with a fluid warmer and much, much more. Anyone want to play doctor?

Besides all the physiological monitoring tools, the MedEx 1000 also has a data storage and transmission system, a control-and-display unit, hot-swappable batteries, ethernet connectivity and the ability to connect to other devices. Initial deliveries are coming the first quarter of 2009. Prices weren't immediately available, but I'm assuming it'll be pretty cost prohibitive for anyone who wants one “just in case.” [LStat via Oh Gizmo]

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<![CDATA[Sexual Gadgets Can Now Be Seized at US Borders Too]]> First it was liquid bottles. Then laptops. And now they are seizing our penis extensors, penis pumpers, and other sexual gadgets. The FDA is saying that they represent a real risk and federal border agents have now a guideline to confiscate them at US territory entry points. The list would be hilarious if it weren't so surreal and stupid:

• Mechanical stretching devices, which "employ weights or lines tied to other parts of the body such as the knee, to affect tension on the penis.

• Vacuum operating devices, "those employing a sealing principle in the area of the base of the penis and an evacuation mechanism to drop the atmospheric pressure around the penis, thereby affecting increased blood flow."

• Constrictive rings, which "constrict the base of the penis after erection has been achieved and cause the erection to be maintained by blocking the normal circulation of blood from the penis."

• Supportive devices, which "function as a splint or cradle in order to maintain a resemblance of turgidity."

Actually, it is hilarious. It almost gave me a browner. These points are part of their new guideline revision for "external penile rigidity devices." Seriously, what about those people with built-in inflatable devices? Can they travel? What's next on the list? Chocolate penis hats? Robotech Thrusters? Pink blowjob machines? Rubber penis builders?

We demand answers! This safety law's nonsense to achieve a false sense of security has to stop at once. [Star Telegram]

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