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Startup lab Theranos scales back unique 'finger prick' blood tests
Theranos, the $9 billion Silicon Valley startup that promises blood test results with just a finger prick, is under serious scrutiny. According to The Wall Street Journal, FDA investigators recently showed up unannounced to inspect its laboratory, due to concerns about the data the company voluntarily submitted for approval of its testing methods. So far, the FDA has only approved one (for herpes) of the 100 Theranos tests waiting for its endorsement. Since the agency also marked the "nanotainers" -- containers that can keep tiny amounts of blood -- Theranos uses as "unapproved medical devices," the company was forced to stop drawing blood by pricking patients' fingers unless it's to check for herpes. In short, it has almost completely stopped doing what makes the startup unique, making it like any other lab, with needles, syringes and such. Update (10/16): Founder Elizabeth Holmes had an interview with Jim Cramer on CNBC today (you can view it after the break), and Theranos has published another blog post promising "Unprecedented transparency." It confirms that the finger prick tests are only being performed to check for herpes, saying that it sought out and asked the FDA to review and fully clear its technology for other tests.
Your doctor may soon check your heart with a smartphone
The stethoscope, invented 200 years ago because a French doctor was too embarrassed to put his ear directly against a woman's chest, is finally getting a digital upgrade. A device called the Eko Core, which attaches to a regular stethoscope, has just been approved for medical use by the US FDA. It amplifies and records the sound signals transmitted by the ubiquitous medical devices, then sends the sound waves wirelessly to an iPhone app. From there, doctors can record the waveform and either listen to it later or compare it to a future visit to test the effects of a treatment. It will also be handy as a teaching too for medical students.
FDA demands Kim Kardashian remove Instagram pill ad
The FDA sent Kim Kardashian a warning letter last week, demanding that she remove an Instagram post in which she endorsed a bottle of Diclegis morning sickness pills but failed to mention any of the potential side effects associated with the product. Kardashian is a paid promoter of the product, which is made by Duchesnay USA. Her post "misleadingly fails to provide material information about the consequences that may result from the use of the drug and suggests that it is safer than has been demonstrated," according to the FDA.
ICYMI: 3D-printed meds, old-man exoskeleton and more
#fivemin-widget-blogsmith-image-397166{display:none;} .cke_show_borders #fivemin-widget-blogsmith-image-397166, #postcontentcontainer #fivemin-widget-blogsmith-image-397166{width:570px;display:block;} try{document.getElementById("fivemin-widget-blogsmith-image-397166").style.display="none";}catch(e){}Today on In Case You Missed It: An exoskeleton to mimic the effects of aging is teaching empathy and also, helping engineers develop technology to help older people. 3D-printed medication is officially happening, now that the U.S. FDA has given its approval to a drug manufacturer. And the world's biggest plane is being built which is intended to launch satellites into orbit.
FDA approves a drug made using 3D printing
You might be familiar with the concept of 3D-printed medical equipment, but you're going to have to get used to seeing 3D-printed medicine, too. The US Food and Drug Administration has approved its first drug manufactured using 3D printing, Aprecia's epilepsy-fighting Spritam. The medication uses a porous, 3D-printed formula to help deliver even very high doses (as high as 1,000mg) while remaining easy to swallow -- all you have to do is take a sip of liquid to quickly disperse the drug and get it into your body.
FDA tells hospitals to ditch IV pumps that can be hacked remotely
The Food and Drug Administration "strongly encourages" hospitals to stop using Hospira's Symbiq Infusion System, because it's vulnerable to cyberattacks that would allow a third party to remotely control dosages delivered via the computerized pumps. Unauthorized users are able to access the Symbiq system through connected hospital networks, according to the FDA and the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team. ICS-CERT reported the vulnerability on July 21st and the FDA released its own safety alert on Friday, July 31st. Thankfully, there are no reported incidences of the Symbiq system being hacked.
Federal law would block FDA reviews on e-cigarettes
No, this is not a repeat from 1964. Congress has blocked a funding bill amendment that would have allowed the FDA to review and approve electronic cigarette brands before they hit market. Republican Andy Harris said, "I think most people realize that they are less dangerous than cigarettes, and yet we're subjecting them to a higher level of regulation." However, the World Health Organization (WHO) is now set against e-cigarettes and early research has shown that vaping may have a toxic effect on lung cells. Democrat Rep. Nita Lowey, who introduced the original amendment, said she was "shocked" by the "objectionable" decision to kill FDA pre-market reviews, adding "many of these products are aimed at children."
Gene-modded mosquitoes will fight Dengue Fever in Brazil
The Brazilian city of Piracicaba has a potent new weapon in the ongoing fight against Dengue Fever, which infects more than a million people annually: genetically modified mosquito lotharios Created by Oxitec of Abingdon, UK and bred locally within Brazil, these GM mosquitoes (all of which are male) are designed to crash the local population before they can spread the tropical disease. More than six million have been released throughout Piracicaba since April. When a GM male mates with a wild female, his sapper genetics cause the resulting larvae to die before they can reach adulthood. What's more, the larvae also carry a genetic mutation that causes them to glow red under UV light, giving researchers an easy way to identify them on sight. "It gives an instant readout of how successfully you're driving down the native population," Hadyn Parry, chief executive of Oxitec, told New Scientist.
This device helps the blind navigate by tingling their tongues
Remember the BrainPort, that device that helps the blind get around by sending electrical signals to their tongues? It's finally getting the green light. The Food and Drug Administration has cleared the BrainPort V100 for sale in the US, giving sightless Americans a unique way to augment their perception of the world around them. In its finished form, the BrainPort sends visual signals from a pair of camera-equipped glasses to a set of electrodes that stimulate your tongue based on object characteristics such as distance, movement and shape. You only need to pay close attention to the V100's tingles and vibrations to identify items. It's not the same as restoring vision and won't completely replace guide dogs or other conventional assistance, but it could fill in a lot of missing information.
23andMe gets FDA approval, but only to test rare Bloom syndrome
For over a year now, 23andMe has been effectively banned from offering its US customers health-related genetic tests. The company is still selling its personal DNA kits, but the information it can provide is limited to ancestry-related reports and raw genetic data. The US Food and Drug Administration (FDA) was behind the original clampdown in 2013, but this week it's given the company its blessing for a new test. With the fresh approval, 23andMe can now offer to look for signs of Bloom syndrome, a rare disorder which is characterized by short stature, sun-sensitive skin and increased cancer risk. While this is a specific test, rather than the broader health reports it offered before, 23andMe calls it an "important first step" to offering detailed genetic advice in the US once more.
The FDA will regulate wearables making health claims
Everyone loves the idea of strapping a smartwatch to their wrist and using it to get a bit healthier, but there's a fine line between casual wearables and serious medical devices. It's an important distinction, since while the former can be sold without any sort of oversight, the latter is rightly covered by the FDA's regulations. Since the most recent batch of fitness wearables could be blurring the borders somewhat, the agency has decided to make its thinking on the subject a little clearer.
Appetite 'pacemaker' tells you when you're actually hungry
For some, the biggest challenge of reaching a healthy weight isn't adjusting their diet or getting more exercise -- it's resisting pangs of hunger when they've already eaten enough. They might have a better time resisting that urge after today, as the US Food and Drug Administration has approved a first-of-its-kind appetite controlling device, EnteroMedics' Maestro Rechargeable System. Think of it as a pacemaker for your stomach. The device sits just under your abdomen and sends electrical pulses that both block hunger signals and send fullness signals more often. In theory, you'll lose weight simply because you have a better sense of when to stop.
HealthPatch MD alerts your doctor about heart problems in real time
What's more important than your health? Not much, we think you'll agree. The team behind HealthPatch MD certainly knows our well-being is top of most of our lists -- so it made the aforementioned product to help monitor it. HealthPatch isn't a fitness-tracking wristband or a home health accessory; it's aimed at hospitals, doctors and medical services. What is it? It's a small patch with a module that monitors heart activity (ECG), heart rate (and variability), respiratory rate, skin temperature, activity posture and even fall detection. What makes it interesting is that it's also a connected device, so you no longer need to go to a medical facility to be monitored. You can just go about your normal life.
23andMe's £125 DNA testing service launches in the UK
While more and more technology companies are shifting their focus to include health tracking, none go quite as in-depth as 23andMe. The self-branded "personal genetics company" made its name in the US and Canada for mail-order DNA test kits that provide customers with an overview of their genetic ancestry and provide a risk assessments for certain diseases based on genetic data. That was until its very public spat with the Food and Drug Administration (FDA), which told 23andMe to stop offering disease analysis until it received the medical device classification it needed. The ban is still in place, but 23andMe has continued to offer (with approval) its ancestry-related reports and "uninterpreted raw genetic data" to customers.
Wearable artificial kidney hopes to gain FDA approval soon
As neat as your smartwatch is, there are other existing wearables which, you know, can actually make the world a world a better place -- though that's not to say whatever you have on your wrist now is useless and for pure vanity purposes. Aptly named the Wearable Artificial Kidney, a projected started back in 2008, this medical gadget hopes to make the dialysis process better for patients, thanks in particular to its portability features. As opposed to the more traditional, stationary machines found at hospitals or in homes, which tend to be extremely heavy, the current version of WAK weighs a mere 10 lbs (around 4.5 kg.) and can be attached around a person's waist.
Google-backed 23andMe gets public money for DNA research
Genetic testing firm 23andMe might not be on good terms with the FDA, but it impressed the National Institutes of Health enough for the agency to give it a $1.4 million grant. The money will be used for a two-year project that'll improve the firm's web-based genetic database and make data available (anonymously, that is) for use by external researchers. This will also allow the company to look into the association between genes and health conditions, conduct more extensive surveys to collect data, among other things that it details on its official announcement.
ReWalk rehab exoskeleton goes home with a patient
The FDA may have only cleared the ReWalk exoskeleton for home use just two weeks ago, but it's already finding use outside of hospitals and clinics. Retired US Army Sergeant Theresa Hannigan (shown meeting the President in March) has become the first patient in the US to take one of the mobility machines home, letting her walk and reclaim much of the independence she lost after being paralyzed. The Argo-made gear is expensive to own at nearly $70,000, but the Department of Veterans Affairs plans to cover the cost of ReWalk technology for Hannigan and anyone else who's eligible to use it. The exoskeletons will have some positive side-effects, to boot -- since recipients are much more active, they reduce the chances of heart disease and other conditions that might take them back to a doctor. [Image credit: Debbie Hill-Pool/Getty Images]
FDA details 2013 meeting with Apple
Several Apple watchers are suggesting that the company's next product will be a wearable. When it was revealed a few months ago that a group of senior Apple executives -- including Bud Tribble and Jeff Williams -- had met with FDA officials in December 2013, their beliefs were reinforced further. Typically, what happens in a closed Apple meeting remains forever secret. But with the FDA involved, there's only so much Apple can keep hidden away. The folks at Apple Toolbox filed a freedom of information (FOI) request seeking specific details regarding the topics discussed and the overall framework of the meeting. Three months later, Apple Toolbox received a response from the FDA detailing the major talking points of the discussion. Of particular interest is a tidbit regarding Apple's interest in sensor technologies. Apple sees mobile technology platforms as an opportunity for people to learn more about themselves. With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more. Sensors already exist on medical devices. For instance, Apple's devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA. It's worth pointing out that over the past 18-24 months, Apple has hired a deep team of folks with considerable biometric and sensor technology expertise. The response furnished to Apple Toolbox further lays out a dialogue between the FDA and Apple concerning how the FDA would regulate sensor technologies. The FDA, in this regard, articulates that sensors that merely measure particular data points may not be subject to such regulation. The rules quickly change, however, when sensors are employed not just to inform but to provide diagnostic information. In other words, the underlying use of a particular sensor is what ultimately matters. Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used. If the manufacturer advertises the device for an unapproved use of FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact. Today there are third party peripherals for iOS capable of measuring a user's glucose levels. One shouldn't infer that the mere mention of a glucometer at the FDA meeting means Apple will introduce similar technology. Some have suggested that an "iWatch" could measure a user's gluclose levels, but that's highly unlikely. Such functionality would be a technological and medical breakthrough of the highest order. Non-invasive continuous glucose monitoring (CGM) remains a nut that numerous biotech companies have never been able to crack. To expect such functionality from a first-generation Apple product is ludicrous. Indeed, I've heard from an in-the-know source that Apple at one point (pre-2013) hired a few non-invasive glucose monitoring experts only to let them go upon discovering just how monumentally challenging the problem is. In any event, Apple's meeting with the FDA suggests that Apple is interested in sensor technologies. Coupled with the recent rollout of HealthKit, the Health app, various finds within the iOS 8 SDK, and not to mention Eddy Cue's statements regarding Apple's 2014 product line, this fall might be Apple's most interesting product rollout in quite a while.
FDA makes it easy for apps to give you public health data
Want to know if it's safe to buy an unknown foodstuff or medicine when you're already at the store? You'll have that option soon. In step with the White House's open data efforts, the FDA has launched OpenFDA, a platform that makes it easy for apps to fetch public health data. Developers only need to implement some search code to pull up information; before this, they had to sift through reports or make special requests. OpenFDA only provides data on adverse drug reactions and medication mistakes right now, but it should expand to recalls and labeling after the current trial phase. You'll have to wait for the first FDA-savvy apps to roll out. Still, it shouldn't be too long before you can walk up to the drugstore counter with confidence. [Image credit: AP Photo/Kevork Djansezian]
The US is opening up the Smithsonian's digitized art collection
The White House promised that it would open up government data last year, and it's now expanding those plans in some intriguing directions. For one, it's opening up the Smithsonian American Art Museum's digitized collection; you'll soon get to build apps and other tools using the institution's artwork as a foundation. Even curators don't have that much access right now, the administration says.
