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SmartPill evaluates, evacuates your GI tract
We've seen a number of medical manufacturers with a common goal: getting you to swallow microprocessor-filled horse pills for things like cauterizing small, internal wounds and dispensing drugs -- and now you can add the "evaluation of constipation" to the list! SmartPill is designed to cruise the GI tract, where it measures temperature and pH, provides temporal-spacial analysis, and differentiates between normal and abnormal transit times -- you know, "the usual." The data from the pill is transmitted to a receiver for later analysis by your doctor. As for what happens to the pill itself, we'll let you use your imagination. This one should be available for shipment in January 2010. PR after the break. And please: keep the comments classy.
E-cigarettes contain carcinogens and toxins after all, FDA warns
In case you ever of the mindset that e-cigarettes were somehow toxin free, at least compared to the more traditional smokes, along comes the FDA to shatter your illusions. A report this week from the government agency calls out the product with a safety warning, charging that the cartridges they examined contained "carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze." The FDA says it can't confirm the extent of the health issues, as it's only done limited testing and it hasn't been formally submitted for review, but it doesn't look quite as risk-free as previously touted. Don't say the WHO never warned ya. So remind us again, what's the point in smoking one of these over an old school cigarette?[Via Switched; thanks, flatlander85]
Medtronic's implantable OCD treatment okayed by FDA
Looks like those brain pacemaker researchers are a bit late on this one, as folks at Medtronic are apt to get the jump on advanced OCD treatment given a recent FDA approval of their device. Hailed as the first implantable device "designed to deliver electrical therapy to the brain to suppress symptoms associated with severe obsessive-compulsive disorder," the Reclaim DBS (deep brain stimulation) Therapy was said to be able to treat OCD patients in cases where drugs and psychotherapy failed. Understandably, Medtronic is doing everything it can to get the product out by the middle of this year, and following up on its good fortune, it also proclaimed that it had started up a randomized clinical trial of DBS for treatment-resistant depression. There's no mention of an expected price, but apparently only 4,000 or so will be needed each year.[Via Vos Iz Neias, thanks yossi]
PEAK PlasmaBlade electrosurgery scalpel gets FDA approval
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]
Silk'n light-based hair remover gets FDA approval for home use
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]
G-Trainer "anti-gravity" treadmill gets approved by the FDA
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]
iPods cleared of pacemaker interference charges
In what must surely come as a huge relief to both people with pacemakers and iPods everywhere, the Food and Drug Administration recently released a report confirming that iPods do not, in fact, interfere with the function of pacemakers. According to an article over at Ars Technica, the report was issued following a study by the FDA which concluded that "no interference effects can occur" when an iPod is in proximity to a pacemaker.The FDA decided to conduct this new investigation and release the subsequent report after a student, 17-year old Jay Thaker, conducted his own study of 100 pacemaker-using patients as part of a school science project and concluded that iPods did interfere with pacemakers. In his report, Thaker stated that iPods "can cause cardiac implantable pacemakers to malfunction by interfering with the electromagnetic equipment monitoring the heart."Fortunately, at least according to the newly released FDA report, Thaker's conclusions appear to be unfounded. So, for those keeping score at home, that's a large, well-funded federal agency with lots of highly-trained and experienced medical personnel, one, 17-year old student with no experience or medical training of any kind, zero. I know, try to contain your surprise. You may now go back to blissfully enjoying your iPods.
iPods won't crash your pacemaker says the FDA
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.
FDA-commissioned study says we don't know much about wireless risks
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.
Satiety's transoral TOGa stomach stapling procedure
Satiety, Inc. has finally found the funding it needs to push forward with a radical new approach to assisting the obese, as it has rounded up $30 million in financing from a number of venture capitalists who dug the idea. Essentially, the TOGa procedure is a "completely transoral process designed to achieve similar weight loss to restrictive surgeries," and it also claims to be less invasive, require less recovery time, and should create a "dramatically reduced amount of complications." In this system, the physician would "introduce a stapling device transorally and create a restrictive pouch at the entry of the stomach," and moreover, it's considered "non-surgical" in nature, endoscopic, and can be performed by properly trained bariatric surgeons, general endoscopic surgeons, and gastroenterologists. Currently, the firm is moving forward with plans to get the procedure approved by the FDA, and while there's no telling how long such a convoluted process will take, stomach stapling could see an entirely different approach in the years to come if this proves effective.[Via CNET]
Infrascanner: the handheld NIR hematoma detector
As technology continues to make doctors' lives a bit easier (not to mention saving a few in the process), we've got yet another device that can detect a potentially fatal problem long before mere humans can figure it out. The Indian-based Infrascanner is a "handheld, non-invasive, near-infrared (NIR) based mobile imaging device used to detect brain hematoma at the site of injury" within the most important stage of pre-analysis. The device could also aid in the decision to proceed with "other tests such as head Computed Tomography (CT) scans" when not "facilitating surgical intervention decisions." While the methods behind the scanning are quite sophisticated, the unit uses diffused optical tomography to convert the light differential data seen in the local concentrations of hemoglobin into "interpretative scientific results." Potentially best of all, however, is just how close this thing is to actually hitting hospital wards, as it's simply missing the oh-so-coveted FDA stamp of approval before it can see commercial use.[Via MedGadget]
HairMax LaserComb now FDA approved -- no, really
Brace yourself Jack... remember the HairMax LaserComb? Yeah, well it's now FDA approved. Seriously, in the FDA trial some 93% of the participants saw an increase in hair density with an average increase of 19 hairs/cm. Of course, that stamp of approval doesn't necessarily mean those lasers will restore your hair, but at least it's not likely to singe the tuft you've got left. Just remember, the FDA also approved Olestra which can cause orificial leakage. Now go ahead, pony-up the $545 required to try 'er out. We sure as hell won't be going hands-on with this one. [Via Physorg.com]
Harmony HiResolution Bionic Ear System gets FDA nod
Nice to see the future, as it looked in the 1970s, finally wrapping its hemp-crocheted arms around us. No, we're not talking jet packs and meals in a pill (though we'd like to be) we're throwin' more bionics at ya instead. The Harmony HiResolution Bionic Ear System from Boston Scientific just got the FDA's good house keeping seal of approval in addition to gaining a nod from Health Canada and the CE mark in Europe. The Harmony System, which combines a cochlear implant and behind-the-ear (BTE) device, delivers 120 spectral bands -- 5-10 times more than competing systems -- to the benefit of the severe-to-profoundly deaf with a love for music. That's right, when the implant is combined with the HiRes Fidelity 120 BTE external sound processor, users will gain access to CD-quality processing to help 'em better appreciate music while the automatic gain control adjusts amplification for soft whispers and loud sounds without adjusting clumsy controls. Approved for adults only in the US and available for that sweet, sweet implant by early 2007.[Via Medgadget]
Portable bone healing system gets FDA nod
Despite having an air of pseudo-science about it, ultrasonic bone stimulation is actually a legitimate non-invasive therapy that's been clinically proven to heal certain types of fractures; and now, thanks to a recent FDA approval, this technology once reserved for fancy hospitals and doctors offices will soon be available for accident-prone individuals to treat themselves right at home. Specifically, the agency just gave the thumbs up to Smith & Nephew's Exogen 4000+ Bone Healing System, which is a portable device designed to stimulate growth in specific fresh fractures along with older ones that have not responded to traditional treatments. Twenty minutes a day is all it takes for a patient to speed up the healing of new fractures by up to 38% or give themselves an 83% chance of successful recovery from those hard-to-heal injuries. Before this new device convinces you to change careers and go all Evel Knievel, though, keep in mind that it's no miracle cure -- in order to completely toss aside concern for your personal safety, you'll have to wait around for those bone-repairing inkjet printers that we've been promised.[Via MedGadget]
