Tag Archives: Device

Medtronic to pay $51 million to resolve U.S. medical device probes

Medtronic to pay $  51 million to resolve U.S. medical device probesMedtronic Plc said on Tuesday it would pay $ 50.9 million to resolve U.S. Justice Department probes into how companies it later acquired marketed medical devices, including one meant to treat a vascular defect in the brain. As part of the accord, ev3 Inc, which Medtronic now owns, will pay $ 17.9 million and plead guilty to a charge related to its marketing of a neurovascular medical device for unproven and potentially dangerous uses, federal prosecutors in Boston said. The misdemeanor charge relates to the Onyx Liquid Embolic System, which the U.S. Food and Drug Administration in 2005 approved for the limited use of blocking blood flow to arteriovenous malformations in the brain.

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Today on Inside Edition: Couple Says They Found Recording Device in Cruise Room; Latest on Pittsburgh Gunman

Today on Inside Edition: Couple Says They Found Recording Device in Cruise Room; Latest on Pittsburgh GunmanA couple who says they found a camera in their room spoke exclusively to Inside Edition.

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'Give Me My Phone Back, Senator:' GOP's David Perdue Snatches Device From Student

'Give Me My Phone Back, Senator:' GOP's David Perdue Snatches Device From StudentGeorgia Sen. David Perdue (R) reportedly grabbed a cell phone from a

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Device to clean-up Great Pacific Garbage Patch could harm wildlife, warn conservationists

Device to clean-up Great Pacific Garbage Patch could harm wildlife, warn conservationists  A controversial scheme to clean up plastic in the Pacific Ocean could harm wildlife and release unnecessary greenhouse gases into the air, conservationists have warned. On September 9th, The Ocean Cleanup foundation will launch a device to sweep up plastic in the Great Pacific Garbage Patch and remove it from the water. The system uses a 2000ft long u-shaped floating cylinder with a 10ft skirt beneath which moves along with the current capturing plastic as it goes. The refuse is corralled into a small area and then picked up by boat every few months and taken to land for processing and recycling. A section of the floating system which will move with the water currents collecting plastic  Credit: The Ocean Cleanup The Ocean Cleanup claims that full-scale deployment of their system could clean up 50 per cent of the Great Pacific Garbage Patch in just 5 years. However marine experts claim the project could do more harm than good. Dr Sue Kinsey, Senior Pollution Policy Officer at the Marine Conservation Society (MCS) said: “We have serious concerns about the Ocean Cleanup and its effectiveness.  “It seems likely that wildlife will be affected, especially the smaller floating plankton that many creatures depend on and those organisms that passively float in the oceans who won't be able to avoid these arrays.    “Also much of this litter is distributed throughout the water column and this may only pick up the surface material.” Some of the plastic picked up from The Great Pacific garbage patch during monitoring  Credit: The Ocean Cleanup  The MCS also warned that the time and energy it takes to collect and return the waste could result in large amounts of greenhouse gases and carbon, and called for organisations to do more to stop litter entering oceans in the first place.  The Great Pacific Garbage Patch, which is located between California and Hawaii is the area where plastic rubbish accumulates because of ocean currents, known as gyres which act like a vortex pulling waste into a central channel. It is around three times the size of Spain. Research by the foundation found that, at its peak, the patch contains around 330lbs of plastic per square mile, reducing to 33lbs at the outer edges. The project to clean up the patch is the brainchild of Boyan Slat, a 24 year old Dutch inventor and entrepreneur, who founded the foundation in 2013. Last month the company published its Environmental Impact Assessment and found there was a ‘medium’ risk to sea turtles who found themselves trapped within the floating tube system. The cleanup system works by using a floating cylinder with a trailing skirt which picks up debris Credit: The Ocean Cleanup A survey of 15 experts by the ecologist and shark researcher David Shiffman of Simon Fraser University in Vancouver also found that it is unlikely that the floating device will clean up a significant amount of plastic without harming wildlife. One in four believed that the entire concept is “a bad idea with little or no redeeming value.” Writing on the website Southern Fried Science Dr Shiffman said: “This device is designed to aggregate objects of a certain size to remove them from the water but cannot distinguish between plastic and living things. The captured plastic will be collected by boats and taken to the mainland for processesing Credit: The Ocean Cleanup Commenting in the survey Eben Schwartz, Marine Debris Program Manager, California Coastal Commission, said: “To make the claim, as the Ocean Cleanup Project is, that they will “clean the oceans” by 2040 or whenever, is disingenuous and misleading, when it will, at best, clean a very small percentage of what’s found on the surface.” However  The Ocean Cleanup said that the device moved slowly enough through the water that any animals would easily have time to escape. “Every year, millions of tons of plastic enter the ocean,” said a spokesman. “The Ocean Cleanup is developing a passive system, that moves with the currents – just like the plastic – to catch it. “”The Ocean Cleanup's passive system is comprised of a floater with an impermeable screen underneath, concentrating the debris before it is extracted by support vessel, while also moving slow enough for sea life to follow the slight downward current as not to be entangled in the system.”

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Apparent explosive device found on Mexican ferry off Cozumel

Apparent explosive device found on Mexican ferry off CozumelPLAYA DEL CARMEN, Mexico (AP) — What appeared to be undetonated explosives were found on a ferry that runs between the Caribbean resorts of Playa del Carmen and the island of Cozumel, authorities said Friday, less than two weeks after a blast shook another ferry plying the same route.

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7th-grader with distraction device shoots himself at school

7th-grader with distraction device shoots himself at schoolMASSILLON, Ohio (AP) — An Ohio seventh-grader who brought a gun to school and shot himself inside a restroom just before classes began on Tuesday also had a device in his backpack meant to cause a distraction, police said.

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This Device Might Help Find Signs of Breast Cancer—but Do You Really Need It?

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We’re all afraid of breast cancer. Let’s get that out in the open right off the bat. It's understandable, considering that breast cancer is the leading type of cancer and the second-highest cause of cancer death (after lung cancer) in women.

Naturally, most of us want to do whatever we can to lower our risk of breast cancer or to catch it early, when it’s easiest to treat. That goal has fueled years of debate over when women should start going for regular mammograms and how often to get them. Personally, after years of reporting on breast cancer screening and other medical exams, I'm leery of looking too hard for something—a concept experts call over-testing, which can lead to over-diagnosis.

RELATED: 9 Things to Know Before Your First Mammogram

Now, there's an at-home device that supposedly can give women even more information about their boobs. The device, called the Pink Luminous Breast, is kind of like a high-tech flashlight. When a woman presses it against her skin, a red LED light illuminates her breast tissue. With your boob aglow, you’re supposed to be able to spot clusters of new blood vessels (called angiogenesis) which can, in some cases, be a sign of possible cancer. Should a women spot shadows or clusters when using the device, she can bring that information to a doctor to see if her breasts warrant further testing.

"We want to inspire an awareness lifestyle,” says Pink Luminous Breast founder Marylin Dans. After having a nodule in her breast removed at age 17, she’s always been extra careful with her breast health, she explains. “I think you should keep it next to your electric toothbrush, turn off the lights, and check yourself every so often. It motivates you to do more self-exams and allows you to feel a little more secure.”

But doctors are skeptical. “I don’t think too many radiologists would recommend this as any sort of screening method,” says Janna Andrews, MD, a breast and gynecological cancer specialist and assistant clinical professor of radiation medicine at the Zucker School of Medicine at Hofstra/Northwell in New York. Because it’s categorized as a class one medical device by the FDA, it can be sold without the stringent clinical testing required of medical devices that can actually diagnosis or treat a condition, Dr. Andrews explains. “We don’t have any evidence of its efficacy or how it compares to mammography,” she says.

RELATED: 9 Breast Cancer Symptoms That Aren’t Lumps

If illuminating your breast did turn up abnormalities, you'd still need a mammogram to know what those irregularities mean. “This is not under the guidance of anybody who is trained,” says Christine Greves, MD, an ob-gyn at Orlando Health Hospital in Florida. If everything looks all-clear with the device, you might be tempted to skip a visit to the doctor. “It may give a false sense of security," she says. "I wouldn’t want anybody to miss anything.”

The device could also cause unnecessary concern. “Clinical breast exams are no longer encouraged because of false positives,” Dr. Andrews explains. Monthly breast exams find too many suspicious lumps that turn out to be nothing to worry about. “I have to think that something like this could potentially lead to more false positives as well.”

Instead, experts recommend sticking to routine mammograms and getting familiar with your breasts the old fashioned way–with your hands. If you feel a lump or notice other changes in your breasts, it’s always worth bringing up with a professional. “If you notice something is feeling a little different than it always has, you can inform your doctor about that,” Dr. Greves says. “Just be aware of your breasts so you can be the first one to know if there’s a change.”

RELATED: All the Ways Your Boobs Change as You Age

The Pink Luminous Breast website says the device “is intended to be a breast health familiarity assistance tool,” something that could help you in the process of getting to know your girls. Personally, I don't see the need to spend $ 149 on a breast health familiarity assistance tool when I have two hands, but Dans disagrees. “I feel awkward doing it—it’s weird to touch yourself,” she says. “What Pink does is it gives you the ability to use a second sense—your eyes—and look underneath your skin.”

I decided to give it a hesitant try. After charging the device for a few minutes, I turned off the lights in my bathroom and bumped up the brightness on the Pink Luminous Breast.

The resulting sorta-creepy red illumination made me feel like I was a passenger on Ms. Frizzle's Magic School Bus. I checked out a few different vantage points, pausing as I looked at shadowy veins, all of which seemed pretty normal to me. Still, I found myself becoming a little queasy about peering into my body so intimately. So I powered down the device, feeling more awkward about looking at blood vessels than I do about feeling myself up.  

I still have more than a decade to decide when to have my first mammogram. But a mammogram—or at least an appointment with a doctor—is the only way to figure out what to do with the information gleaned from using the Pink Luminous Breast. Trying it out left me wondering what would have happened if I was more of a worrier about my breast cancer risk. Would I have booked an appointment for the following day? 

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In most women with an average risk of breast cancer, screening doesn’t start until at least age 40 and sometimes later. But Pink Luminous Breast’s website says women over 25 should start using the device. “Even in a woman with a very high risk of breast cancer, we typically don’t recommend starting screening before age 30,” Dr. Andrews says. That’s because women in their 20s have just a 0.1% risk of developing breast cancer in the next 10 years, according to the American Cancer Society. For women in their 30s, that number rises to just 0.5%. Younger women also have denser breasts, which might obscure the view. “I would have to think it would not be as effective in dense breasts,” Dr. Andrews says.

For now, I'm sticking to old-fashioned, device-free breast familiarity. Both Dr. Andrews and Dr. Greves expressed gratitude that Pink Luminous Breast wants to help women, but they didn't think it built a strong enough case to ignore current standards of care just yet. Bottom line, says Dr. Greves: “We can’t recommend or endorse a product that’s not fully regulated or FDA approved.”

www.health.com/breast-cancer/pink-luminous-breast “>
Breast Cancer – Health.com

Investors Urge Apple To Tackle ‘Growing’ Evidence Of Device Addiction In Kids

Investors Urge Apple To Tackle ‘Growing’ Evidence Of Device Addiction In KidsTwo major Apple shareholders are calling on the company to do more to protect children from the potentially harmful side effects of excessive technology use.

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Mother charged after putting recording device in daughter's backpack to catch 'bullying' 

Mother charged after putting recording device in daughter's backpack to catch 'bullying' A mother has been charged by police in the US after putting a recording device in her daughter’s backpack to catch alleged bullying. Sarah Sims, from Virginia, admitted to local news website WAVY she placed the electronic recorder in her nine-year-old daughter’s bag to record classroom conversations after suspecting she was being bullied. She claims her emails and calls to Ocean View Elementary school, Norfolk, about the alleged bullying in September went unanswered and so she decided to intervene. However the recorder was discovered and Ms Sims was later charged with the use of a device to intercept oral communication, which carries a maximum five-year prison sentence, and a misdemeanor contributing to the delinquency of a minor. “I tried to be fair, but it’s not fair,” she told WAVY. “There is nothing fair about this. “The thing that bothers me the most is that I am yet to get a response from anyone in the administration. “If I’m not getting an answer from you what am I left to do?” Ms Sims said she was “mortified” after being charged by police, adding: “The next thing I know I’m a felon. Felony charges and a misdemeanor when I’m trying to look out for my kid.” Her solicitor, Kristin Paulding, said the school “aren’t making this about that classroom”, adding: “There are charges that carry jail time. “Instead of comforting her she’s going to a magistrate and being handcuffed.” Ocean View Elementary told WAVY it could not comment on an ongoing investigation. The school district said recording devices were banned in elementary schools. Ms Sims is due in court for a preliminary hearing on January 18.

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Inventor of 'bump stock' spent years fighting for device, and lost

Inventor of 'bump stock' spent years fighting for device, and lostFor years, Bill Akins fought to capitalize on his idea – with the U.S. government, his former business partner and a rival competitor – but found himself stymied at every turn. The 63-year-old Marine veteran and Elvis impersonator voiced his sorrow at the tragedy in Las Vegas, where authorities said Stephen Paddock had bump stocks installed on 12 of his rifles. “I would like to express my dismay and sincere condolences to the victims, families and anyone affected by the recent Las Vegas mass shooting,” Akins said during a telephone interview from his home about 45 minutes north of Tampa, Florida.

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