Items tagged with FDA

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... Read more...
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... Read more...
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,... Read more...
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... Read more...
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... Read more...
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. ... Read more...
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... Read more...
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... Read more...