July 25th, 2008 by
Filed under: Misc. Gadgets
We’re still a bit gun shy when it comes to surfing over to PEAK Surgical’s website after watching that PlasmaBlade demonstration video, but a new release from the outfit affirms that said electrosurgery scalpel has just been approved for use by the US Food and Drug Administration. The “tissue dissection system,” as it’s so gruesomely called, has been given 501(k) clearance, meaning that PEAK can now market its tool for use in general surgery. So, anxious to camp out and be the first in the country to get sliced and diced by one of these? Bombard your local hospitals with phone calls starting next month.
[Via MedGadget]
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Posted in health, medical, surgery, medicine, fda, electrosurgery, peak, peak plasmablade, PeakPlasmablade, plasmablade, scalpel, approval, PEAK Surgical, PeakSurgical | No Comments »
March 25th, 2008 by
Filed under: Misc. Gadgets
Believe it or not, this actually isn’t the first FDA approved personal hair remover we’ve come across, but for those looking for something capable of handling some seriously hairy ordeals, look no further than Silk’n. Created by Home Skinovations (har har), this unit relies on proprietary Home Pulsed Light technology to zap unwanted hair and bring back the smooth. Of course, this thing still has to be used “under the direction of a physician,” but after waltzing into his / her office with three inches of sprawling chest hair blossoming from under that halfway buttoned shirt, we’d wager you’ll have the requisite signature in no time.
[Via medGadget]
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Posted in health, laser, hair, fda, hair removal, HairRemoval, head, Home Pulsed Light, Home Skinovations, HomePulsedLight, HomeSkinovations, pulse, scalp, Silk’n | No Comments »
February 20th, 2008 by
Filed under: Misc. Gadgets
Alter-G looks to have been boasting about its G-Trainer “anti-gravity” treadmill for some time now, but it seems that it’s now a whole lot closer to finding itself under your feet someday, as it has now been approved as an actual medical device by the FDA. In case it didn’t pop up on your radar, the device itself makes use of a specialized air pressure regulation system to reduce the individuals’ effective body weight by up to 80%, with it apparently precise enough to make changes in increments as small as 1%. Of course, Alter-G also seems to be quite confident that the rig is entirely safe but, given some of the predicaments we’ve seen other, seemingly innocuous treadmills get in, we’d still be a little cautious about strapping ourselves into the thing.
[Via MedGadget]
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Posted in treadmill, fda, alter-g, g-trainer | No Comments »
February 1st, 2008 by
It turns out that 17-year-olds probably aren’t that good at studying electrical interference — and its effect on pacemakers — created by iPods. Unlike the data presented to the Heart Rhythm Society last year by a high-school student, which demonstrated the music player’s ability to interfere with heart-regulating devices, the FDA now says that the gadgets are completely safe for use. Researchers measured magnetic fields produced by four different models of Apple’s ubiquitous device, and found no reason why your grandmother can’t keep jamming to her South of Heaven reissue. Said FDA researcher Howard Bassen, “Based on the observations of our in-vitro study we conclude that no interference effects can occur in pacemakers exposed to the iPods we tested.” We hope the FDA will follow this up with a definitive study on the effects of boomboxes on hip implants.
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Posted in Apple, ipod, study, elderly, fda, electrical interference, ElectricalInterference, food and drug administration, FoodAndDrugAdministration, ipods, pacemaker, pacemakers | No Comments »
January 21st, 2008 by
Filed under: Cellphones
Just in case our long-running series of posts regarding the danger / safety of cellphone and WiFi radiation didn’t tip you off, an FDA-commissioned study was just published by the National Research Council of the National Academies of Science that basically says we’ve got a lot left to learn about the effects of all those radio waves. The FDA wanted to know where to concentrate research efforts in order to better understand wireless safety, and it looks like there are quite a few gaps in the research: the study says there needs to be further study on the effects of wireless radiation on children, pregnant women, and fetuses, both long- and short-term, and that frequency and power differences between different types of radiation need to be better understood in order to apply current knowledge to new products. All in all, it looks like there’s a lot we don’t know — but that’s not going to stop us from rocking this Bluetooth headset while browsing and taking a call.
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Posted in Dangerous, studies, fda, not dangerous, NotDangerous | No Comments »
