CVS, Walgreens Among Companies Flagged by FDA for Selling Sketchy Eye Drop Products

https://gizmodo.com/fda-cvs-walgreens-selling-sketchy-eye-drop-products-1850834761


The Food and Drug Administration is warning several companies, including the retail chains CVS and Walgreens, to stop selling unapproved, potentially dangerous eye drop products. The agency claims that the companies have committed a number of violations in manufacturing or marketing these products. The FDA is also worried about the inclusion of silver compounds in some products, since silver can turn people’s skin or eyes permanently blue with long-term use.

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The FDA announced Tuesday that it was issuing warning letters to eight different companies regarding their eye drop products. These companies include CVS Health and Walgreens Boots Alliance, Inc, both of which own retail pharmacy chains that sell store-brand versions of popular over-the-counter drugs and healthcare products. Other flagged companies such as Similasan and Boiron produce products commonly sold in retail or online pharmacies.

The FDA alleges that the cited eye drop products sold by these companies are illegally marketed. The labeling of these products often includes language claiming that they can treat or cure conditions such as conjunctivitis (pink eye), cataracts, glaucoma, and others. As a general rule, however, anything sold in the U.S. that explicitly claims to fix a medical problem needs to have been cleared, authorized, or approved by the FDA beforehand, and the agency says that these products have not gone through that process.

Some of the eye drop brands have also allegedly been made at facilities that have recently failed to meet standard manufacturing guidelines for product safety and quality, including the eye drops sold by CVS and Walgreens. The FDA further says that these two eye drop brands in particular are labeled to contain silver, ostensibly used as a preservative. While silver can be used medicinally (often for its antimicrobial properties), the FDA is worried that its inclusion in eye drop products could be dangerous. Long-term consumption of silver as a drug is known to potentially cause a condition called argyria, which can turn our skin, internal organs, and soft tissues (including those of the eye) permanently blue.

“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the agency said in its announcement.

Many of the products mentioned by the FDA in these letters are additionally branded as homeopathic remedies. Homeopathy is a not-so-ancient form of alternative medicine that has no good evidence for its effectiveness in treating any medical problem. The agency notes that people using unapproved products such as these might delay or stop using products that have actually been proven to be safe and effective for their intended use.

The companies are expected to respond to the FDA within 15 days on how they will correct their alleged violations. Failing a response, the agency has the ability to take further steps, including legal action to seize or stop the manufacturing of these products. The FDA has also added some of the companies to a list of import alerts, which allows the FDA to detain products shipped from overseas without examination before they can enter the country.

“When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, in a statement. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”

via Gizmodo https://gizmodo.com

September 13, 2023 at 02:03PM

Swiss students just set a mind-bending EV acceleration record

https://www.autoblog.com/2023/09/13/swiss-students-just-set-a-mind-bending-ev-acceleration-record/


Last year, a team of German students set a world record for the fastest-accelerating electric car, pulling 2.5Gs while reaching 62 mph (100km/h) in a staggering 1.461 seconds. Now, that record has been shattered by another team of students from Switzerland, whose car just crossed the one-second threshold.

The AMZ team’s car, named Mythen, made the 0-62 mph (0-to-100 kph) run in just 0.956 seconds, knocking more than half a second off the previous team’s record – a lifetime in any sort of timed automotive event. Research team members from ETH Zurich and the Lucerne University of Applied Sciences and Art built the car, which took just 12.3 meters to break the acceleration record.

Built by hand, the stubby-looking car weighs just 140 kg (around 309 pounds) and is powered by a custom 321-horsepower engine. AMZ’s head of aerodynamics, Dario Messerli, said, “Power isn’t the only thing that matters when it comes to setting an acceleration record; effectively transferring that power to the ground is also key.” He went on to describe the way Formula 1 cars use downforce to achieve that power transfer and said that the team developed a vacuum system to effectively suction the car to the ground.

That’s an approach McMurtry Automotive took with its mind-bending Speirling EV, which is now for sale with a more than $1 million price tag. The track-only (for now) car can hit 60 mph in 1.4 seconds and run the quarter mile in 7.97 seconds. The company credits its aerodynamic design over its purported 1,000 horsepower as the driving force behind its performance.

The Speirling has two turbines behind its cockpit that suck the air from underneath the car, allowing it to outrun cars like the Rimac Nevera. However, all of that still doesn’t match the effort put in by the Swiss team, but at least the Speirling has a roof.

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September 13, 2023 at 11:02AM

France Says the iPhone 12 Is Radioactive

https://gizmodo.com/france-says-the-iphone-12-is-radioactive-stops-sales-1850833545


French regulators halted iPhone 12 sales on Tuesday over concerns that the devices emit levels of radiation over the legal limits. The government’s Agency of National Frequencies (ANFR) said it will send agents to Apple stores to ensure the devices aren’t being sold, and threatened to recall all iPhone 12s in circulation if the company doesn’t address the problem. Apple said its phones comply with international radiation guidelines.

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Hours before Apple announced the iPhone 15 at its “Wonderlust” event, France’s radiation watchdog announced that iPhone 12s were temporarily withdrawn from the French market “due to non-compliance of these devices with European regulations.” The ANFR said tests found that the phone’s “specific absorption rate,” which measures the level of electromagnetic waves absorbed by the human body, was over limits set by the European Union.

EU standards set allowable radiation levels lower than standards in Asia and North America out of an abundance of caution, in the typical consumer-friendly European regulatory mode. Barrot told Le Parisien the EU standard “is ten times lower than the level of emissions which, according to scientific studies, can have consequences for users,” (translated from French).

The ANFR found the iPhone 12’s specific absorption rate exceeds the legal limit at a distance of five millimeters, a test set to replicate the radiation exposure when a phone is in your hand or pants pocket. At a distance you’d expect for a phone in a jacket pocket or a bag, radiation from the iPhone 12 is within legal limits.

Apple did not immediately respond to a request for comment, but told Reuters that the iPhone 12 was certified as compliant with global radiation standards by multiple international bodies.

It seems the problem isn’t inherent to the design of the device. Jean-Noel Barrot, France’s junior minister for the digital economy, who oversees the ANFR, reportedly told Reuters that a software update could fix the problem. “Apple is expected to respond within two weeks,” Barrot said. “If they fail to do so, I am prepared to order a recall of all iPhones 12 in circulation. The rule is the same for everyone, including the digital giants.” Barrot said he expects the ANFR’s finding would cause a “snowball effect” of similar action from other countries in the EU.

Before you dunk your iPhone in concrete, understand that most electronic devices emit radiation. The word “radiation” often brings images of mushroom clouds to mind, but radiation is the just name for energy that travels through space, and it isn’t necessarily dangerous. Not all radiation is “ionizing” radiation, the kind that can melt your skin off or alter your DNA at high levels. The heat given off by a candle is a form of radiation, for example, and it’s safe at a distance of a few inches.

Cell phones communicate using microwaves, the same frequencies used by WiFi and the microwave in your kitchen, as the name implies. (That explains the interference that makes your voice sound like a robot on phone calls sometimes, or causes the WiFi cuts out in some houses when you heat up a Hot Pocket.)

There’s a conspiracy theory — and a small amount of evidence-based medical debate — that suggests the radiation emitted by cell phones is dangerous. However, the current medical consensus is that cell phones are safe.

via Gizmodo https://gizmodo.com

September 13, 2023 at 10:33AM

Forza Motorsport’s Blind Drive Assist Is A Breakthrough For Gaming Accessibility

https://kotaku.com/forza-motorsport-xbox-blind-accessibility-options-race-1850829331


Recent Forza games have been trailblazers for upping the ante when it comes to accessibility. 2021’s Forza Horizon 5 came with in-game sign language for cinematics, and a time-slowing option for those with slower reaction times. Incredible stuff. This October’s Forza Motorsport is aiming to push the boundaries even further, introducing a mode designed for blind players, called Blind Drive Assist.

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Steve Saylor, a blind games player, has recently tested it out, and tweeted to describe how the suite of audio cues and customizations work.

The ensemble of aural guidance appears to combine the co-driver spoken guidance more familiar to rally driving games, in which upcoming turns are described, along with what essentially boils down to sophisticated sonar. A collection of bleeps, bloops and tones that tell a player where their car is on a track relative to its sides and turns, and when they need to brake or accelerate.

Steve Saylor

Saylor was able to play a specific track in the unreleased car-tuning racing game, and described his first attempt to use the audio cues as “a cacophony of sound.” Then, after meticulously adjusting the volume meters and tone levels of all the different sounds to suit him, Saylor said his racing considerably improved. In the video above, he explains how fixing these settings, and getting familiar with the cues, eventually saw him winning a race.

There’s often a lot of confusion about what “blind” means, with many assuming it’s a term for seeing nothing whatsoever. This isn’t the case; rather, it describes visual impairment, where sight is affected to a degree that vision is seriously altered. Steve Saylor describes this eloquently, with excellent visual explanations, in this video.

With audible indicators informing a player where they are on a track using stereo sound, alongside sonar-like feedback for how close they are to barriers, accompanied by cues for when to brake or accelerate, Forza Motorsport becomes an aural experience with visuals to support. Which is, to our knowledge, a first for racing gaming.

Other accessibility options include removing car collisions for single-player gaming and turning AI cars into ghosts, along with audio descriptions for cutscenes and extremely specific volume options for every aspect of the game’s sounds.

Forza Motorsport, the eighth game in this branch of the Forza franchise, comes from the same studio that has developed every entry, Turn 10 Studios. The studio worked with accessibility consultant Brandon Cole to develop the Blind Drive Assist mode, along with support from Saylor. It’s due out October 10, with four-day early access for those who pay for the eye-wateringly expensive Premium Edition.

 

via Kotaku https://kotaku.com

September 12, 2023 at 10:28AM

Short Naps Can Improve Memory, Increase Productivity, Reduce Stress And Promote A Healthier Heart

https://www.discovermagazine.com/health/short-naps-can-improve-memory-increase-productivity-reduce-stress-and


Napping during the day is an ancient custom that is practiced worldwide.

While some people view napping as a luxurious indulgence, others see it as a way to maintain alertness and well-being. But napping can come with drawbacks as well as benefits.

As an orofacial pain specialist, I have extensive education in sleep medicine and how sleep impacts wellness, due mostly to the relationship between sleep and painful conditions such as headaches and facial pain. My training involved all aspects of sleep, especially sleep breathing disorders, insomnia and sleep-related movement disorders.

As such, I’m aware of the complex nature of napping, and why a short nap – that is, a nap during the daytime that lasts from 20 to 30 minutes – may be beneficial in myriad ways.

An abundance of health benefits

Research shows that there are many benefits to napping. Short naps can boost mental functioning and memory, as well as improve alertness, attention and reaction time.

Short naps are also linked to increased productivity and creativity. Because napping seems to improve creative thinking, some companies have attempted to harness this by introducing napping rooms into the workplace.

What’s more, it appears the brain uses nap time to process information gathered throughout the day, which appears to enhance problem-solving abilities. One small study revealed that people who took short naps were less frustrated and impulsive, which resulted in better focus and efficiency when performing work-related tasks. Napping may even lead to an improved ability to learn new motor skills, such as a golf swing or the playing of a musical instrument. This is because these memories or skills become consolidated in the brain during sleep, whether at night or while napping.

Napping can also reduce stress. One study found that naps of approximately 20 minutes improved the overall mood of participants. However, longer naps lasting more than 30 minutes are not typically associated with improved mood and increased feelings of well-being.

Short naps may also be associated with a reduced risk of cardiovascular diseases. If we are awake more than we should be, we tend to have a buildup of the “fight or flight” chemicals in our bodies. Studies show that more consistent sleep will help lower these chemicals, resulting in a normalization of blood pressure and heart rates. Napping appears to help this process for some people.

But just as in nighttime sleep, some people may have trouble drifting off for a nap, especially when they have limited time. Progressive muscle relaxation techniques have been shown to be beneficial for both nighttime sleep and napping. Other nonspecific relaxation techniques, like listening to relaxing music, appear to also be beneficial for falling asleep. Interestingly, many people overestimate their time awake when trying to sleep and underestimate the time they actually spent sleeping.

Napping can have drawbacks

One condition associated with napping longer than 30 minutes is sleep inertia – the grogginess and disorientation that people sometime experience after waking from a longer nap.

Usually, the longer the nap, the more sleep inertia there is to overcome. This can impair cognitive function from several minutes up to half an hour. In many cases, these effects can be minimized by consuming caffeine directly after the nap.

But it is important to note that caffeine is not a substitute for sleep. Caffeine acts to temporarily block the action of a chemical known as adenosine, a sleep-promoting agent that builds up during waking hours. If you are habitually dependent on caffeine consumption to keep you awake and alert, it may suggest that there is an underlying sleep disorder such as insomnia or sleep apnea, in which a person temporarily stops breathing during sleep.

Long or late afternoon naps can also interfere with nighttime sleep, either by leading to difficulties falling asleep or staying asleep during the night. This disruption of the regular sleep-wake cycle can result in overall sleep deprivation, which can have numerous negative health effects.

What’s more, for those age 60 and up, longer naps – beyond 30 minutes – may increase the risk for cardiovascular problems. Researchers found that older adults taking naps for more than one hour per day have a higher incidence of increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels, sometimes known as metabolic syndrome.

The reason for this phenomenon is mostly unknown. Older individuals tend to nap more frequently than younger adults partly due to more disturbed sleep during the night. This could be related to more pain or other health factors that will interfere with sleep, sleep altering medications and altered sleep rhythms seen with aging.

Best practices

So, to maximize benefits while reducing risks, here are some tips: Keep naps short to avoid sleep inertia and nighttime sleep disruptions. Nap in the early afternoon, as that aligns with a decrease in energy levels after lunch and with the body’s natural circadian dip, which is an increase in sleepiness similar to what occurs at dusk. Avoid late afternoon naps, finish naps at least four to six hours before bedtime, and create the right environment by napping in a quiet, comfortable and dimly lit space.

If you’re struggling with daytime sleepiness, it’s best to address the root cause rather than relying solely on napping. Reducing caffeine consumption, maintaining a regular sleep schedule and getting adequate nighttime sleep are essential steps to reduce daytime sleepiness.

Ultimately, napping should complement a healthy sleep routine, not serve as a substitute for sufficient nighttime rest. A balanced approach to napping can contribute to a more energized, focused and resilient life.


Steven Bender is a Clinical Associate Professor at Texas A&M University. This article is republished from The Conversation under a Creative Commons license. Read the original article.

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September 8, 2023 at 08:48AM

Biometric implant monitors transplant patients for organ rejection

https://www.engadget.com/biometric-implant-monitors-transplant-patients-for-organ-rejection-180045215.html?src=rss

Researchers at Northwestern University developed a bioelectric implant that can detect temperature fluctuations that typically happen right before a body rejects an organ transplant. The sensor is smaller than a fingernail, and a mere 220 micrometers thick.

This new sensor technology is thin enough to sit directly on a kidney’s fibrous layer — called the renal capsule — which surrounds and protects the organ. The device works by continuously monitoring changes to blood flow and temperature. The built-in thermometer can sense increases as minuscule as 0.004 degrees Celsius. Once an irregularity is detected, the sensor, which contains a micro coin cell battery for power, uses Bluetooth to alert a patient or physician via a smartphone or tablet. Any increase typically signals inflammation which is a potential sign of transplant rejection.

After any surgery that involves an organ transplant, the risk of rejection is high. The sensor was developed specifically for kidney transplants but it could also work for other organs, including the liver and lungs. Kidney transplants in the US are on the rise and are usually recommended for people who will not be able to live without dialysis. The American Kidney Fund cites that an acute rejection of a kidney transplant one month after surgery happens in about five to twenty percent of patients that go under.

That’s why it is critical to detect transplant rejection, which occurs when your body’s immune system treats the new organ like a foreign object and attacks it. If a healthcare provider detects signs of rejection early enough, medical intervention can preserve the new organ in the new host. Northwestern researchers said that the device detected warning signs of organ rejection three weeks earlier than current monitoring methods. The current “gold standard” for detecting rejection is a biopsy, where a tissue sample is extracted from the transplanted organ and then analyzed in a lab. However, biopsies are invasive and can cause bleeding and increase the risk for infection.

An infrared camera glows red where the thermometer detects a subtle source of heat.
Northwestern University

Despite developing an innovative first-of-its-kind product, researchers at Northwestern University still have a long way to go. It still needs to be tested on humans in a clinical setting before it can make any impact in the surgical market. Northwestern’s John A. Rogers, a bioelectronics expert who led the device development, said in a statement that his team is now evaluating ways to recharge the coin cell battery so that it can last a lifetime.

This article originally appeared on Engadget at https://ift.tt/4s1kTQB

via Engadget http://www.engadget.com

September 7, 2023 at 01:09PM

How To Play Starfield Without An Xbox Or PC

https://www.gamespot.com/articles/how-to-play-starfield-without-an-xbox-or-pc/1100-6517520/


10 years in the making, Bethesda’s sci-fi RPG Starfield has finally landed, and while the game is only sold on Xbox and PC, those aren’t the only platforms where the game is playable right now. Thanks in part to Xbox Game Pass, Starfield is actually available across a wide variety of devices, so you don’t even need a console–let alone a beefy PC–to play the ambitious spacefaring game. You will, however, need a controller of some type to play Starfield.

Xbox Game Pass Ultimate subscribers automatically get access to cloud gaming, which opens up a host possibilities for where and how they can play Starfield. This is all part of Microsoft’s ambition to think beyond the console as it looks to the future.

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One benefit of playing Starfield over the cloud is that there is no local download required, and players are always updated to the latest version of the game. The game does not run locally but on outside servers, so Starfield can be played on the phone you might have in your pocket right now. And it should boot up near instantly, again, without any local download required.

Something to keep in mind, though, is that a strong and consistent internet connection is necessary for cloud gaming to be at its best. Also worth considering is whether or not you have a data cap because streaming takes up a good amount of bandwidth. Streaming might also not be the optimal experience for Starfield in terms of imagine quality and latency, in case those are important factors for you.

Starfield was reportedly originally in development for PlayStation and might have been exclusive to Sony’s console like Bethesda’s Ghostwire: Tokyo and Deathloop were at launch. Microsoft Gaming CEO Phil Spencer said when Microsoft caught wind that Starfield could be exclusive to PlayStation, this drove him to pursue an acquisition of ZeniMax and Bethesda.

Play Starfield on your phone or tablet

Anyone with an Android or iOS phone can play Starfield via the cloud. Players need the Xbox Game Pass mobile app on Android, and from there, they can play anything in the Game Pass catalog that supports cloud gaming. Android users need to run OS 6.0 or newer, and iOS must be updated to 14.4. The iOS version, meanwhile, brings you to a browser to stream Starfield and other games.

iPads are supported, too, provided they are updated to version 14.4 or newer. Android tablets work as well, as long as they’re updated to 6.0.

Play Starfield on your TV without an Xbox

Microsoft and Samsung have partnered up to allow Game Pass Ultimate subscribers to play Starfield through the Samsung Gaming Hub. This is supported on 2022 and 2023 Samsung TVs, as well as monitors and the Freestyle 2nd Gen portable projector.

2020 and 2021 Samsung TVs also support Starfield through the Xbox app. In fact, support for 2020 model Samsung TVs was just added today, September 6, for the launch of Starfield.

Samsung TVs support standard Xbox wireless controllers, as well as PlayStation’s DualSense and DualSense Edge gamepads. The Xbox Adaptive controller is supported as well, as is Amazon’s Luna controller, the Nvidia Shield controller, newer Logitech controllers, and many more. You can see a list of supported devices on Samsung’s website. Samsung also supports the Amazon Luna virtual controller, which is free to download.

Play Starfield on Steam Deck

Valve’s handheld device, the Steam Deck, supports Xbox cloud gaming, and that means it supports Starfield. It’s not the most intuitive to get started, however. You can read GameSpot’s in-depth, step-by-step guide for how to get Xbox Game Pass running on Steam Deck to play Starfield.

Play Starfield on PlayStation Portal?

Sony’s PlayStation Portal streaming device isn’t the the first device that comes to mind when you think about Starfield, but many are theorizing that Starfield might actually work on the device. The $200 device reportedly runs on a version of Android. While it might not be simple or straightforward–or even allowed in the terms of use–you can imagine modders might find a way to get Starfield running through the Game Pass app for Android. Again, nothing is confirmed here, but modders are known for simply… finding a way.

Now that Starfield is in the hands of players, people are making major discoveries, like how having sex every day is a good way to level up and how to print infinite money. It’s also been discovered that Starfield has really good potato physics. For more, check out GameSpot’s Starfield guides hub, and take a look at the gallery below to see Starfield’s best weapons and learn how to get them.

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September 6, 2023 at 02:02PM