Items tagged with FDA

A company backed by Elon Musk, Neuralink, has gained FDA approval to launch its first-in-human clinical study. The company stated on Twitter that it is the result of the Neuralink team working closely with the US Food and Drug Administration (FDA) and represents the first step that one day will allow the technology to... Read more...
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... Read more...
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... Read more...
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... Read more...
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... 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... 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... 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... 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... 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... 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... 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... Read more...