Items tagged with FDA
We talked not too long ago about a study that had found that the Apple Watch might be usable for detecting high blood pressure and sleep apnea, thanks to the sensitivity of its heart rate monitor and an accompanying app. This week marks the first actual FDA approved accessory for the Apple Watch that is able to monitor health conditions, which just so happens to be the KardiaBand by AliveCor. The device is a personal electrocardiogram or EKG. The KardiaBand connects to the Apple Watch like any other accessory band, but it has tech inside that allows the wearer to discreetly take their heart rate and capture EKG data from nearly anywhere. The band is reportedly able to quickly detect a normal...
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Would you trust your life to a hacker? No, of course not, and neither does the US Food and Drug Administration. The FDA issued a recall of nearly half a million pacemakers after the organization discovered a vulnerability that makes several models susceptible to hacking. Once exploited, a hacker would be able to control the device's pacing and deplete the batteries. "Many medical devices - including St. Jude Medical's implantable cardiac pacemakers—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there...
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At HotHardware, we unfortunately have to frequently write about security and privacy breaches, and those breaches can seriously affect their victims. But while a cyberattack on a bank might make for a bad day, nothing could compare to a cyberattack on equipment that helps keep their owners alive. If you have a family member using a pacemaker, for example, you want to be confident in its ability to thwart potential attacks. The Food and Drug Administration wholeheartedly agrees, and it proves it through in-depth guidelines for makers of life-saving devices. The FDA doesn't sugar-coat the importance, stating, "Failure to maintain cybersecurity can result in compromised device functionality, loss...
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Biometric monitoring via wearables appears to be the Next Big Thing, as far as the biggest tech companies are concerned. Samsung is on its second generation of smartwatches (with a new generation already rumored), Google is expected to reveal much more about its Android Wear wearable platform next week, and Apple’s iWatch is allegedly coming to market this autumn. However, for the perspective of the average user, biometrics are only so compelling. Sure, it’s neat to be able to monitor your heart rate from your wrist or track your steps, but that’s just it--they’re merely “neat” features. However, according to a Reuters report, the big aforementioned companies...
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Dean Kamen, the inventor of the Segway, lead a DEKA Research and Development team that built an amazing prosthetic arm that they affectionately call “Luke” (after the handless hero of Star Wars), and that arm has now been approved for sale in the U.S. by the FDA. What makes the Luke DEKA Arm System so compelling is that it uses electrodes attached to a user’s muscles--be they shoulder, arm, leg, or whatever muscles a given patient can use--to control a five-fingered robotic hand that has movement in all five digits as well as the wrist. Source: DARPA According to Bloomberg, it can perform six grip patterns and detect up to ten movements from the user’s brain. Users can...
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We’re actively resisting the urge to make a pun about apples a day keeping doctors away, because Apple is reportedly getting into the health monitoring technology market with a future iOS 8 app called “Healthbook”. The New York Times spotted some interesting names on a public FDA calendar, including several Apple employees: SVP of operations Jeff William, VP of software Bud Tribble, Michael O’Reilly, and Tim Powderly from the company’s government affairs department. Image Source: concept-phones.com The fellow who spotted the December meeting, attorney Mark A. McAndrew, told the NYT that based on the personnel present, “They are either trying to get the lay...
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If you were planning to purchase a $99 DNA test kit for the holiday season, you may have to put those plans on hold. The U.S. Food and Drug Administration ordered 23andMe, a Google-backed DNA analysis company, to stop sales of its genetic testing kit since they're being sold without marketing clearance or approval. "FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said in a statement. "The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work." 23andMe sells a $99 Saliva Collection Kit and Personal Genome Service, which tells users if they're genetically predisposed to some 260 diseases...
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Little Kaiba Gionfriddo was born with a condition where his bronchus would collapse and cut off airflow to his lungs. He would stop breathing from time to time, and eventually he was admitted to the hospital and diagnosed with tracheobronchomalacia. His parents were told that he had a low chance of survival. Baby Kaiba’s doctors reached out to doctors Glenn Greene and Scott Hollister at the University of Michigan, who were developing a 3D printed bioresorbable device that could save Kaiba’s life (and anyone else born with that particular affliction). The tiny tracheal splint essentially widens the bronchus and also provides support and stability so it doesn’t collapse. 3D-printed...
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Just in case you hopped right down to the news and missed the fresh link at the top of the page, we’re writing to let you all know that we have just posted a new article here at HotHardware in which we evaluate the features and performance of Intel’s recently released, Wolfdale-based Core 2 Duo E8500 processor. The E8500 uses Intel’s 45nm Penryn derived Wolfdale core, with a 3.16GHz clock speed, 6MB of L2 cache, and support for SSEE4.1. Overall, even in its stock configuration this processor was a strong performer, while consuming less power than Intel’s previous generation 65nm products. But while overclocked to over 4GHz on air-cooling alone, it put up some truly impressive...
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Intel fans have been patiently waiting for the company to release their lineup of refreshed Core 2 Duo and Quad products. Intel started hyping these revised components late last year, and they were expected to hit the market in January of this year. While Intel technically hit that date with the release of one 45nm component, it was the ultra-expensive Core 2 Extreme QX9650, which sells for over $1,000. Not really the type of component that everyone can get their hands on. Nevertheless, the current generation of 65nm Core 2 products continued to fall in price, and with no real competition from AMD’s Phenom X4 lineup, there really hasn’t been too much of a problem with Intel’s delays. In...
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A little over a year ago at the Intel Developers forum in San Francisco, Intel allowed a small group of members of the technology press to run benchmarks on a pre-configured Conroe-based system, well before processors based on the Conroe core had begun to ship. This was a new strategy for Intel, but a welcomed one in our opinion as it gave enthusiasts a chance to glean some real information about an upcoming product well before it actually hit store shelves. Intel continued to employ this strategy in the weeks leading up to the launch of the Kentsfield core. Once again, in a closed door session in a briefing room at IDF in California, Intel gave is the chance to run some...
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