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FDA approves a life-like prosthetic arm from the man who invented the Segway
After years of testing, the FDA today approved a new type of prosthetic arm that its makers claim will bring a whole new level of control to amputees. Known as the "Luke" arm or DEKA Arm System, Segway inventor Dean Kamen has been involved in its development and unlike existing prosthetics, it can understand multiple commands at once, giving its wearers "near-natural" control of the limb. As demonstrated in the videos embedded after the break, tests show wearers can get back to easily performing tasks like using keys and locks, brushing their hair, removing papers from an envelope, or picking up an egg without breaking it. While we've seen demos using other mind control techniques, the one approved for sale does its magic with electromyogram (EMG) sensors activated by the wearer contracting muscles close to where the prosthesis is attached or on their feet, which an embedded computer translates into movement.
FDA's new e-cigarette regulations target 'healthier than tobacco' claims
Proposals to officially regulate electronic cigarettes will be announced later today by the Food and Drug Administration, according to the WSJ. The regulations would include a ban on sales to minors and a requirement for health warning labels on packaging. E-cigarettes contain nicotine liquid, which is derived from tobacco -- and that's where the FDA comes in. "Right now it's like the wild, wild west in terms of what people are doing.." Importantly, makers would not be allowed to state that e-cigarettes are safer than other tobacco products ( manufacturers need to provide scientific evidence to prove these claims), nor use descriptive language like "light" or "mild" to describe goods. Companies will also be required to submit a "pre-market review application" within two years, although products will be allowed to stay on the market as long as the application is filed. Outlines will also restrict marketing on TV and any efforts to appeal to anyone under 18, although they won't immediately ban the wealth of flavored e-cigarettes that have recently flourished. FDA Commissioner Dr. Margaret Hamburg told ABC News: "Right now it's like the wild, wild west in terms of what people are doing, the products are evolving with no regulatory oversight and being marketed in ways that are very worrisome." The full list of regulations will be posted online by the FDA at 9am today.
23andMe stops selling DNA health tests following FDA crackdown (updated)
If you've been mulling over getting screened by 23andMe for genetic risks like cancer, we're afraid you'll have to look elsewhere. The company has just announced that it's suspending sales of its health-related personalized DNA kits its health-related genetic tests to comply with the FDA's order, as the agency has yet to conduct tests to prove its accuracy. In a blog post on the company website, co-founder Anne Wojcicki says she's "committed to making sure that 23andMe is a trusted consumer product." For now, the company is focusing on research and ensuring those who purchased a kit before November 22nd still get their results. Folks who bought one after that date will, unfortunately, have to make do with a refund. Oh, and it's worth adding that the company will still offer paternity testing and will happily send you your raw genetic data -- there just won't be any color commentary provided alongside. Update (12/7/13): Well, it looks like 23andMe will continue selling test kits, just not returning health reports to anyone who bought after November 22nd, while the company continues its dialogue with the FDA. A spokesperson told us anyone who buys a kit can still get the firm's Personal Genome Service, which includes genetic ancestry information and raw genetic data.
FDA orders 23andMe to stop selling DNA-testing kits pending approval
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, and sent a letter to its customers: 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.
Majority of medical apps won't be FDA regulated
App catalogs are flush with titles that allow users to play doctor, but according to the FDA, most of them are harmless and don't warrant regulatory oversight. Instead, the agency has announced that it'll take a more reactive, risk-based approach and will only require approval for mobile apps that "present a greater risk to patients if they do not work as intended." Specifically, the FDA will scrutinize apps that perform the functions of regulated medical devices -- such as an ECG monitor -- along with those that are used as accessories to regulated medical equipment. As a telling statistic, only 100 mobile apps have received FDA clearance within the past decade, so imagine what would happen to the agency's workload if it tried to exercise control over the Apple App Store and Google Play Store combined.
FDA, ICS-CERT issue warnings for medical device, hospital network security
Reports that medical devices implanted in patients or used for their treatment may have dangerous vulnerabilities are not new, but a new "safety communication" is focusing more attention on the issue. Ars Technica points out that the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) group that works along with private industry to protect the nation's infrastructure issued its own alert alongside the FDA's, focusing on the many embedded devices that are protected only by hard-coded passwords. The ICS-CERT message recommends restricting physical access to sensitive hardware, improved designs that are more resistant to potential attacks and increased network security. The FDA lists various vulnerabilities it's become aware of like network connected devices being infected by malware, mobile devices being targeted to access patient data, the previously mentioned hard-coded passwords issue and more. Going forward, the FDA is collecting reports of "adverse events" to determine if security has been compromised, and will issue new guidelines on mobile health technology later this year. We've seen examples of potential security solutions for pacemakers in the past, and the more connected healthcare devices become we're sure patients expect any potential vulnerabilities to be addressed as well.
FDA cracks down on uChek app, working on stricter rules for medical apps
Bloomberg reports that the FDA on May 22 sent a letter to the makers of a biomedical iPhone application named uChek. The app, when accompanied with a separate test strip kit, helps users to perform a self-urinalysis and subsequently monitor a number of health indicators such as protein and glucose levels. These test results can help provide insight into the status of "carbohydrate metabolism, kidney and liver function, acid-base balance and bacteria." Back in February, we reported: The product works by leveraging the iPhone's highly sensitive camera to read tints from inexpensive urine dip stick tests. Developed by Mumbai-based Myshkin Ingawale, an MIT grad, the app shifts monitoring away from expensive clinics and into the home. The app was put on the market by Ingawale's startup, a company called Biosense, and works by using the iPhone's camera to analyze test strips normally designed for visual assessment. On iTunes, the company indicates that the app should only be used with the recommendation of a qualified healthcare professional. That apparently isn't enough for the FDA. Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. ... The Food and Drug Administration has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices. Under the FDA's current proposal, the agency would wield some regulatory and approval power over a select number of mobile apps that pose the most risk to consumers in the likelihood of an app not working as intended. Official guidance on the extent of the FDA's role in the approval of medical apps will be finalized later this year, according to FDA spokeswoman Synim Rivers. Biosense, meanwhile, has indicated that it is open to working with the FDA "to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world." In the meantime, the FDA will wait and see how Biosense responds to its inquiry. Following that, Rivers explained the agency may issue a "warning letter that sets out specific violations of the law must be addressed immediately." You can check out more information as to how the app works over here on uChek's website.
Breathometer lets phone users keep alcohol in check from a keychain (video)
Who knew that smartphone owners were suddenly such temperate drinkers? Just days after Alcohoot unveiled its take on a phone-friendly breathalyzer, Breathometer is here with its own way to watch our tipsiness. The namesake, FDA-approved gadget will plug into the headphone jack of an Android or iOS device and warn if our blood is too alcohol-rich, all while staying small enough to fit on a keychain. Plans are underway to eventually let soused users hail a taxi from the native app. The Breathometer won't be available until we're at the height of summer party season, but it should be cheap enough to eliminate any excuses: its Indiegogo campaign is asking for just $20 to secure a Breathometer alongside a pledge, or less than a good night out.
Google adds medication to the Knowledge Graph, might ease our minds through search
It's no secret that many of us turn to Google searches for medical advice, much to the chagrin of doctors who have to contend with periodic bad attempts at self-diagnosis. Google might not have a cure for hypochondriacs, but it can stop all of us from taking risks at the pharmacy: it's adding medicine to the Knowledge Graph. Search for medication and the side results panel will bring up data from the Department of Veterans Affairs, the FDA and the National Library of Medicine. Apart from a very top-level summary of a drug's role, the Knowledge Graph will show alternative names, related drugs and (most importantly) risks. The search firm is quick to warn that it's not giving us a license to prescribe our own treatment -- we'll want to talk to someone who swore the Hippocratic Oath, if there's more than a headache. The depth of Google's new search tool could still do more to assuage worried patients than a pill bottle label.
FDA approves Proteus Digital Health's e-pills for dose monitoring
An "ingestible sensor" doesn't sound like the tastiest of snacks, but soon it might be just what the doctor ordered. A tiny microchip which activates upon contact with stomach acid has recently been given the green light by the US FDA. When the sensor is swallowed, an external patch picks up its signal and shoots a message over to whoever it's supposed to. The technology is aimed at tackling an issue known in the healthcare biz as compliance -- or, following instructions. Correct timing and dose are important for many drugs, and lax schedules can be responsible for treatment failures or the development of nasty drug-resistant bugs. Although the pills have only been used in trials, one pharmaceutical heavyweight has already bagged a license to the technology for real-world applications. If you don't like the thought of a belly full of microchips, no need to worry -- the harmless sensors pass naturally after completing their mission.
MIT's LiquiGlide could spell the end of slow-moving ketchup nightmares (video)
A team from MIT has decided to end slow-pouring ketchup problems once and for all with its LiquiGlide project. Instead of karate-chopping the 57 logo on the bottle's neck, a super-non-stick coating is sprayed on the inside of its glass container. It's so good that even highly viscous liquids like ketchup and mayonnaise roll out of the bottle and onto your dinner as if it was water. All the chemicals used are already FDA approved, meaning that it's already safe to be used in food production. If adopted, it'd save around one million tons of trapped sauce from being wasted every year. Since we already have finely-honed ketchup-fu skills, we're hoping the LiquiGlide technique also finds its way into peanut butter jars.
FCC grants radio spectrum to muscle-stimulating wireless devices for paralysis patients
The medical community is all smiles today, because the FCC has decided to allocate a chunk of radio spectrum for potentially life-altering wireless devices. Designed for stroke patients and those suffering from brain or spinal cord injuries, these so-called medical micropower networks (MMN) use a set of implanted electrodes and a wearable wireless controller to stimulate the muscles of a paralyzed user. In a statement issued last week, the FCC announced that these devices have been approved for use within the 413 to 457MHz range, as requested in a petition from the Alfred Mann Foundation, which has already constructed several prototype MMN systems. The organization's CEO, David Hankin, immediately lauded the ruling, adding that the Foundation now plans to launch trials of MMN systems on humans, in the hopes of receiving clearance from the FDA. "The FCC's decision removes the most significant roadblock to helping people," Hankin said. "The frequency that has been approved for use is the most efficient for penetrating tissue with radio waves and without which the new generation of our implantable neurostimulator technology would be impossible to advance." The significance of the occasion wasn't lost on FCC chairman Julius Genachowski, either. "These broadband-enabled technologies are life-changing, impacting individuals, families, and communities in ways we can only begin to imagine," Genachowski said in a prepared statement. His sentiments were echoed in remarks from fellow commissioner Mignon Clyburn, who heralded the decision as "one of the most important the commission has adopted during my tenure," citing its potential to "greatly improve the lives of those who are faced with some of today's most difficult medical challenges."
FDA drafts Mobile Medical Applications document
There are all manner of medically-based uses for iOS devices (the iPad in particular) if you are a medical professional, so it was just a question of time before patients themselves got in on the act (brace yourself, we get all bureaucratic up ahead). According to the Juvenile Diabetes Research Foundation, the FDA has drafted a document titled Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications which is a first pass at attempting some standardization and looking at regulating the data and communication requirements of apps like this (for example, having a glucose monitor that can sync readings to your iOS device). Particularly for a condition like diabetes, which requires tracking and (sometimes frequent) monitoring, it's very handy to have all that data available quickly and easily. Having an official stance, even in draft, is a big step forward. From the JDRF: Once the information is on a smartphone, diabetes management will become more discrete while at the same time opening up a world of opportunity. You could view glucose levels, determine insulin requirements and make dosing decisions, track your treatment, and share all of this information seamlessly with the people that help with and matter most to your care. You could send alerts and alarms automatically to parents or caregivers, and receive helpful advice when needed. If this is something you're in favor of, or better yet, could actually use, now's your chance to add your voice to the encouragement. Here's the catch: You only have until October 19th to have your say. You'll find feedback on the JDRF post that you can use as an example to work from. If you or someone you know could benefit from this, take a moment and fill out the comment form. Who knows? Your comment may be the one that puts it over the edge and turns this draft into reality.
Hair transplant robot gets FDA approval, men with straight brown hair rejoice
Back in 2007, we told you about Restoration Robotics, an upstart research team using robots to perform hair transplants -- a project whose details (you know, like how it works) were shrouded in secrecy. Four years later, the Artas System has won FDA approval for in-office procedures, with the inviting bot in the above photo harvesting individual hair follicles from the scalp. A few months after this robot operates on your cranium, hair will start growing back, a process that could take a year -- and makes for a more gradual transformation than slapping on a toupee. Still, you'll have to be a certain kind of man to take advantage of this technology -- for now at least, it's only been cleared for men with black or brown straight hair. Looks like the rest of you will have to find other, lower-tech ways to suffer for your beauty.
Portable brain tumor treatment system kills cancer while you take out the trash
We've seen robots that perform brain surgery and lasers that cook tumors, and now a team of researchers are well on their way to bringing mobility to the battle against brain cancer. The NovoTTF-100A, which just received FDA approval, is basically a set of insulated electrodes, attached to an electronic box, that pumps low intensity electrical fields to the site of a freshly diagnosed GBM (glioblastoma multiforme) tumor. The fields, known as Tumor Treatment Fields (TTF), play off the electrically charged elements of cancer cells to stunt the tumor's growth, and may in some cases actually reverse it. A recent test of the system showed comparable results to chemotherapy, without the usual lineup of side effects, including nausea, anemia, fatigue, and infection. Given, patients using the system are expected to wear the thing continuously, but we'd say walking around with a cap full of electrodes is a small price to pay for giving cancer the boot. Full PR after the break.
Brain-controlled robot arm kicks off new FDA program to speed up approval of medical devices
As we've seen, the FDA approval process for medical devices and other gadgets can be a long one, but it looks like things could soon be speeding up considerably. The agency has just announced a new "Innovation Pathway" program that promises to allow for priority reviews of "truly pioneering technologies," which could potentially cut the approval process time in half. Somewhat ironically, however, that program itself will first need some further review before it's broadly deployed, but the FDA has already kicked things off on a limited basis with its first submission: a brain-controlled robotic arm from DARPA. It's not clear which arm that is, but it sounds a lot like the now-famous "Luke" arm developed by Dean Kamen's Deka organization, which just so happens to be funded by DARPA. Head on past the break for the official press release, and a video of the FDA's webcast announcing the program. Update: A tipster has pointed out that the robotic arm in question, and seen briefly in the video after the break, is actually the Modular Prosthetic Limb developed by Johns Hopkins University's Applied Physics Laboratory (now pictured above), not Deka's Luke arm.
Mobisante's MobiUS smartphone ultrasound system secures FDA clearance, now needs to graduate from WinMo
The concept of a smartphone-based ultrasound imaging system is far from new, but Dr. Sailesh Chutani -- Mobisante's CEO and a former bigwig at Microsoft -- is bound and determined to take things beyond the drawing board. The aforesaid company has just landed what may in fact be the most important part of the production puzzle: 510(k) clearance from the US Food and Drug Administration. That's a major seal of approval, and pretty much allows the company to move forward with plans to get ultrasound technology into remote villages and rural hospitals where it's simply not feasible to purchase a $20,000+ system. Of course, there's still many years of work between now and then; the existing build only works on Toshiba's WinMo-based TG01 smartphone, and current estimates still put a $7,000 to $8,000 price tag on the whole MobiUS package. If it can reach critical mass, it's hoping to halve that asking price, and if things keep progressing, this may very well be the company that makes an ultrasound stethoscope a reality. Here's hoping this is just the firm's first celebration of many to come.
Zelrix electronic anti-migraine patch heads to the FDA for review
We've seen some electronic devices that promise to cure migraines in the past, but NuPathe's Zelrix patch certainly seems to be among the most practical, and it's just gotten one step closer to the US market. The company recently announced that the FDA has accepted its filing for a New Drug Application, and it says it now has a target date of August 29, 2011 for the FDA to complete its review. As for the patch itself, it's a single-use patch that relies on a mild electrical current to "actively transport" the anti-migraine drug sumatriptan through the skin using a process called iontophoresis. That, NuPathe says, not only allows for a more consistent and controlled delivery of the drug, but it also circumvents the nausea and vomiting that can occur when taking the medication orally -- which the company notes can be enough to cause some folks to avoid taking the medication altogether. Head on past the break for the complete press release.
New research says e-cigarettes are safer than real ones, no cigarettes safer still
Research swayed back and forth on the health risks associated with e-cigarettes since their debut in the US about three years ago. The faux cigs, which are essentially nicotine inhalers intended to help smokers kick the actual smoking habit while still getting their dose of nicotine, the main addictive ingredient in tobacco. In the first truly comprehensive study of the somewhat controversial nicotine replacement method, researchers at Boston University's School of Public Health has found that not only are e-cigarettes much safer to "smoke" than normal ones, they may also aid in kicking the addictive habit altogether. According to the researchers, "few, if any" of the chemicals found in e-cigarettes pose serious health risks, and carcinogen levels in them are up to 1,000 times lower than in actual tobacco. This research, of course, disagrees with the FDA's findings that essentially, the chemicals found in e-cigarettes were risky and unknowable. The FDA has yet to evaluate e-cigarettes the way that they have done with all medications and other nicotine replacement products, so we can't be sure, but it's looking more and more possible that if you just need to smoke, an e-cigarette may be a safer route... for everything but your dignity, of course.
Telescopic eye implant approved by the FDA
We love eye implants, and we've seen our share of them, and this one is pretty sweet (although it isn't the creepiest by a long shot -- that prize would go to the one that uses a human tooth to hold its lens). In the works for well over a year, and approved by the FDA a couple days ago, VisionCare Ophthalmic Technologies' implantable miniature telescope is intended for patients over 75 years of age who are suffering from end-stage macular degeneration. As with any tricky new surgery, this one is not without risks, including the need for a corneal transplant due to the device's size. According to CBC News, in clinical testing seventy-five percent of over 200 patients "had their vision improve from severe or profound impairment to moderate impairment," and there are two more studies on the way: one will follow up with existing patients, while the other will outfit 770 new patients with the device. The cost? $15,000.
