Airport Scanners OK for People with Implanted Heart Devices: Study

WEDNESDAY, May 8, 2019 — It appears to be safe for people with implantable heart devices such as pacemakers and defibrillators to go through body scanners at airport security checkpoints, researchers say.

Body scanners are becoming increasingly common worldwide.

But some people are concerned that they may be a source of electromagnetic interference (EMI) that could disrupt implantable devices used to treat abnormal heart rhythm (arrhythmia).

Patients with these devices are advised to limit their exposure to certain technologies, including metal detectors, magnets and MRI scans.

The study authors surveyed 1,000 patients with pacemakers, defibrillators and other cardiac implantable electronic devices (CIEDs). Eighty percent expressed concern about passing through airport body scanners.

Researchers then analyzed more than 1,000 body scans of people with CIEDs. The scans did not affect functioning of the heart devices, and no CIEDs were detected by the scanners.

The study, to be presented this Friday at the Heart Rhythm Society’s annual meeting in San Francisco, is the first to examine body scanners’ impact on CIEDs. Research presented at meetings is typically considered preliminary until published in a peer-reviewed journal.

“We were surprised to learn that so many patients expressed concerns about the functionality of their devices while traveling. We wanted to help put their minds at ease by testing the potential interference body scanners could have on common devices like pacemakers and defibrillators,” lead author Dr. Carsten Lennerz said in a meeting news release.

Lennerz is a senior physician at the German Heart Centre in Munich.

“Our study results show that now patients can travel worry-free knowing they can safely go through security checkpoints without the need of disclosing personal medical information,” he added.

More than 3 million people worldwide have pacemakers, a common type of CIED, to control abnormal heart rhythms.

More information

The American Heart Association has more on devices for arrhythmia.

© 2019 HealthDay. All rights reserved.

Posted: May 2019

Drugs.com – Daily MedNews

Medicine Man Releases Three a Light Home-Grow Weed App for Apple Devices

If you’re thinking about starting a cannabis grow in your house but aren’t an expert botanist, don’t worry: There’s now an app for that. The first app to offer personal horticulture services specifically for weed launched on the Apple App Store at the end of January.

Three a Light, released by cannabis consulting firm Medicine Man Technologies, is based on the book of the same name that uses simple methods to teach regular people how to increase their yields — up to three pounds per light, thus the name of the book — from their cannabis plants. Adults 21 and up and medical marijuana patients in Colorado are allowed to grow anywhere from six to sixteen plants at home, depending on a variety of factors, including where they live and if they have a medical marijuana card.

Joshua Haupt, the chief cultivation officer at Medicine Man Technologies (a cannabis consulting firm owned by the same potrepreneurs behind Medicine Man dispensaries), first published the book Three a Light in 2015 after helping his friends in the Rocky Mountains grow for themselves. “I had a lot of friends with medical issues,” he says. “I made them a little pamphlet that was like, ‘Follow these steps,’ and everyone used it.”

His friends encouraged him to go bigger than a pamphlet, so Haupt wrote Three a Light, filling it with photos and illustrations explaining how to grow the plant to its full potential. There was a hole in the market for this type of book, according to Haupt, who believes there still isn’t literature available that explains the cultivation process from start to finish in a way that the weed-illiterate can understand.

After being out for a few years, he says, the book still maintains a high rating (it currently has a 4/5 rating on Amazon), so why the need to make an app? Shortly after the book came out, Haupt saw a need for customer service. And the most valuable piece of the app, he believes, is the interactive support it provides. The app holds much of the book’s content in a sleek design, with photos for each step of the cultivation process as well as a nutrient calendar and schedule for feeding. Users can sync their plants into the calendar and receive notifications for cultivation reminders.

But the coolest part of the app is the feature that lets growers talk with master growers.

For example, a grower struggling to identify a pest could upload a picture of it to the app and get a response during the company’s business hours. The master growers answering questions have all worked in grow facilities and have thousands of hours of experience working with Haupt.

“Essentially you just get the keys to the castle with the app in your hand,” Haupt says. “You get oversight from people who have been doing this on a much larger scale.” His goal is to help the cannabis industry become more successful and lower wholesale prices of cannabis, while also imparting necessary growing skills to people who need the plant for medical purposes and are choosing to grow at home to save money.

While both the book ($ 500) and app ($ 99.99) prices aren’t pocket change, they aren’t much compared to the startup costs of a home grow — or underperforming plants. “It’s a very expensive learning curve,” Haupt explains. “If you do something wrong, you could lose thousands of dollars.” He says he’s able to double the amount of cannabis yielded per plant through a combination of tactics, including a process called “schwazzing,” which involves defoliating the plants at specific times of the growing cycle.

“If you have a license to grow cannabis, you have a license to lose money — a lot of it,” Haupt says. “This is truly farming, so it’s not gonna be easy. You’ve got to earn every dollar.”

Toke of the Town

Heart Devices 101: Guide to the Tools That Keep You Ticking

SUNDAY, April 2, 2017 — Pacemakers, defibrillators and other medical devices have saved the lives of millions of people worldwide.

Someone you know probably has received one of these heart-health enhancers, although not all have become household words.

The U.S. Food and Drug Administration evaluates and regulates these and other medical devices in the United States. Below, the agency provides a brief glossary of terms that might come in handy when a doctor recommends a cardiac tool:

Heart pacemakers: These small, battery-powered devices are implanted in the body. They deliver an electric shock to restore normal heart rhythm when the heart beats too slowly.

Implantable cardioverter defibrillators: These deliver a shock to restore normal heart rhythm when the heart beats too fast.

Automated external defibrillators: These portable, automatic devices are found in many public locations. They help restore normal heart rhythm when someone’s heart suddenly and unexpectedly stops pumping blood (cardiac arrest).

Cardiac ablation catheters: These are long, thin flexible tubes that are threaded into or onto the heart to treat abnormally rapid heartbeats. They work by modifying small areas of heart tissue that are causing abnormal heart rhythms.

Cardiovascular angioplasty devices: These long, thin, flexible tubes are threaded into a heart or other blood vessel to open narrowed or blocked areas in order to increase blood flow to the heart, reduce chest pain and treat heart attacks.

Prosthetic (artificial) heart valves: These are used to replace diseased or dysfunctional heart valves, which direct blood flow through the heart. There are mechanical valves made of man-made materials and valves made from tissue taken from animals or human cadavers.

Stents: These are small tubes inserted permanently into an artery to improve blood flow. Some also contain drugs that reduce the chance that arteries will become blocked again.

Ventricular assist devices: These mechanical pumps help weak hearts pump blood effectively. While originally intended for short-term use until a donor heart became available, the devices are now also used as long-term treatment in patients with severe heart failure who do not qualify for a heart transplant.

Heart disease is the leading cause of death in the United States, according to the U.S. Centers for Disease Control and Prevention.

More information

The U.S. National Heart, Lung, and Blood Institute has more on heart disease treatment.

Posted: April 2017

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Drugs.com – Daily MedNews

Face-Saving Devices: Seat Belts and Air Bags

FRIDAY July 22, 2016, 2016 — Seat belts and air bags significantly reduce the risk of facial fractures in car crashes, a new study finds.

“Based on our analysis, we found that use of an air bag alone reduced the likelihood of a facial fracture by 18 percent while use of a seat belt alone decreased likelihood by 43 percent,” said study co-leader Dr. Scott Chaiet, a head and neck surgeon at the University of Wisconsin when the study was conducted.

“Use of both decreased the chances of facial fractures in a crash by 53 percent,” he added in a university news release.

Researchers analyzed 2007-12 data from more than 518,000 people in the United States who required treatment at a trauma center after a motor vehicle collision. More than 56,000 (nearly 11 percent) suffered facial fractures — nasal and mid-face fractures most often.

Those most likely to suffer facial fractures were younger males who didn’t use or have safety devices in their vehicles.

Of those who suffered facial fractures, almost three out of five had no safety device. Nearly 6 percent had air bag deployment only; 27 percent had a seat belt only, and less than 7 percent had both.

“The trend in reduction in facial fractures with the use of air bags and seat belts can be attributed to advances in airbag technology over the last 10 to 15 years,” said study co-leader Dr. David Hyman, an otolaryngology resident at the university.

The study was published July 21 in the Journal of the American Medical Association.

More information

The U.S. National Highway Traffic Safety Administration has more on vehicle safety.

Posted: July 2016

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FDA Seizes Counterfeit Drugs, Devices Sold Online

International effort takes aim at more than 1,050 websites

WebMD News from HealthDay

By Robert Preidt

HealthDay Reporter

THURSDAY, June 18, 2015 (HealthDay News) — The U.S. Food and Drug Administration, along with international partners, moved this week against more than 1,050 websites that sell potentially dangerous counterfeit medicines and medical devices, the agency said Thursday.

Illegal medicines and medical devices were seized worldwide, and warnings were sent to the operators of offending websites, the FDA said in a news release.

“Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease,” said George Karavetsos, director of the FDA’s Office of Criminal Investigations.

Counterfeit prescription drugs that claim to be generic versions of brand-name drugs that are sold illegally on the websites include generic Nolvadex, generic Meridia, generic Valium, generic Truvada and generic Advair Diskus, according to the FDA.

Mail screenings in Chicago, Miami and New York found that some of these counterfeit drugs — which included antidepressants, hormone replacement therapies, sleep aids and drugs to treat erectile dysfunction, high cholesterol and seizures — were on their way to American consumers, the FDA said.

Bogus medical devices sold on websites that were targeted include hyaluronic acid and other dermal fillers and “colon hydrotherapy” products. Dermal fillers are used for concealing facial wrinkles.

As part of the international effort led by Interpol, the FDA said it sent warning letters to the operators of nearly 400 websites selling unapproved or misbranded prescription medicines to U.S. consumers, and to nine companies distributing unapproved medical devices online.

This operation “provides yet another avenue for the FDA to engage with our international law enforcement partners on these critical issues,” Karavetsos said.

“We are not only pleased to be a part of this strong international enforcement effort, but resolved to do everything we can to ensure that the global problem of illegal Internet drug and device sales is deterred as a result,” he added.

Potential health risks are one obvious danger posed by illegal online pharmacies and medical device sellers, the agency said. Other threats to consumers include credit card fraud, identity theft and computer viruses, the FDA added.

WebMD Health

Xenoblade Chronicles 3D Raises the bar for RPGs on portable devices, Dev Says

Xenoblade Chronicles for Wii

Tetsuya Takahashi, director at Xenoblade Chronicles 3D developer Monolith Software says that he never imagined the game would be available to play on handheld devices when it was originally made for Nintendo’s Wii, but now that it is, it raises the bar for portable role-playing games.

“Now we can play Xenoblade Chronicles on the New Nintendo 3DS XL, and…now, this may sound a little egotistical, but I thought, ‘This is really going to raise the bar for RPGs on portable devices,'” Takahashi said in the latest Iwata Asks interview series, in which Nintendo president and CEO Satoru Iwata sits down with different developers.

Takahashi said he was surprised the game found an audience in the West, and discussed the differences between protagonists in Western RPGs and Japanese RPGs.

“One difference is that [Xenoblade Chronicles] did a good job of incorporating the innate heroism of JRPGs…allowing the user to become the hero, to become the protagonist,” Takahashi said. “On the other hand, games made in the West – and this is only my personal opinion – they are very well made, down to the last detail, but there’s something stoic about them, and often the heroism aspect seems to take a bit of a back seat.”

“In JRPGs, the protagonists aren’t very strong,” Iwata said. “They seem like people you could meet on the street who just happen to be born to a certain destiny, and are drawn by some force into doing things that they could have never believed possible… But if Westerners really didn’t like that kind of story, Star Wars wouldn’t have become such a hit. Because that movie is just this type of story.”

Xenoblade Chronicles 3D is a re-release of Wii RPG Xenoblade Chronicles coming on April 10. It’s the first 3DS game that will require the New 3DS in order to play.

GameSpot

Nintendo Bringing a Mii App to Mobile Devices

Nintendo remains steadfast in its refusal to develop games for mobile devices, but we now know one of the ways it plans to leverage that market to its advantage: a Mii-focused app.

In an interview with Japanese publication Nikkei, Nintendo president and CEO Satoru Iwata was asked about the company’s plans for mobile. He reiterated his hesitation to allow the company to get into the smartphone or tablet games business, stating, “In the past, I have opposed making smartphone and tablet versions of Nintendo titles. Prices for content aimed at smartphones and tablets are falling quickly. I am still wary of the category. We intend to develop products that will allow customers to identify with Nintendo products and make people pay attention to Nintendo games.”

He offered one example of how Nintendo intends to accomplish this: “[S]ome Nintendo game consoles incorporate Mii, which creates a digital avatar to represent players. It would be fun for players to use their Mii characters as icons on social media. We are currently developing an application that will allow users to do that. The app will be announced around the time our full-year results are released.”

Iwata didn’t share any further details, so it’s unclear if the app would have any functions beyond that. Nintendo’s fiscal year runs through the end of March, suggesting an announcement will be made in either April or May.

In a statement to investors last month, Iwata offered a vague outline of Nintendo’s plans for mobile development. A small team is at work on the initiative with a goal of “achieving greater ties with our consumers on smart devices and expanding our platform business.”

“It is our intention to release some application on smart devices this year that is capable of attracting consumer attention and communicating the value of our entertainment offerings,” Iwata added at the time.

GameSpot

FDA Adds ‘Boxed Warning’ to Devices Used to Remove Uterine Fibroids

MONDAY Nov. 24, 2014, 2014 — The U.S. Food and Drug Administration on Monday announced that new “boxed warning” labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.

The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there’s no way to guarantee surgical morcellation wouldn’t increase the risk of spreading cancer to other parts of a woman’s body.

The new warning will let surgeons and patients know that “uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients,” the FDA said in a news release.

Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous,” the FDA added.

That’s because in about one in every 350 cases, women who undergo hysterectomy for fibroids may have an unsuspected uterine sarcoma, the FDA said, and morcellation might help spread that cancer.

“The FDA’s primary concern is the safety and well-being of patients, and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the agency’s news release.

“Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed,” he added.

The FDA did not rule out the safe use of morcellating devices in some patients. The new warning label should help narrow the candidate patient population, however. “For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may [still] be candidates for this procedure,” the agency said in the news release.

Surgeons frequently use laparoscopic power morcellation when they perform a hysterectomy or remove uterine fibroids, which are noncancerous growths on the smooth muscle tissue on the wall of the uterus.

The minimally invasive procedure uses a power tool to chop up the tissue of the fibroids or, in the case of a hysterectomy, the uterus itself. These tissue fragments are then removed through tiny incisions, according to background information from the FDA.

At the end of July, Johnson & Johnson, the largest maker of laparoscopic power morcellators, pulled their devices from the market. In a letter sent to customers, J&J asked that its laparoscopic power morcellators be returned to the company, the Wall Street Journal reported.

About 60,000 of these laparoscopic procedures are performed every year, Maisel estimated.

In April, the FDA stopped short of banning the power morcellation devices from the market, but the agency is urging physicians and patients to weigh the risks involved with the devices prior to their use.

Women who already have undergone power morcellation don’t need to undergo a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.

“We think that most women who have undergone these procedures require routine care,” he said. “If they don’t have any ongoing or recurrent symptoms, they should be fine.”

Most women will develop uterine fibroids at some point in their lives, according to the U.S. National Institutes of Health. These fibroids can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic pain or frequent urination.

Women who need a hysterectomy or fibroid removal can still undergo traditional or laparoscopic surgery, just without the use of a power morcellator, Maisel said.

The FDA approved the first power morcellator for use in 1995, Maisel said. A non-power version of the morcellator received FDA approval in 1991.

More information

For more about uterine sarcoma, visit the U.S. National Cancer Institute.

Posted: November 2014

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Drugs.com – Daily MedNews

Noninvasive Devices May Help Migraines, FDA Says

MONDAY Sept. 22, 2014, 2014 — Two new prescription devices approved by the U.S. Food and Drug Administration (FDA) may provide some relief for people with migraine headaches who don’t tolerate migraine medications well, according to a new study.

One device — the Cefaly — is designed to prevent migraines, while the other device — the Cerena — is meant to be used when migraines first start, according to an FDA news release.

“Patients have been looking for alternative migraine treatments. Because these devices aren’t ingested or metabolized like drug therapies, they don’t necessarily have the same types of side effects,” Michael Hoffmann, a biomedical engineer with the FDA, said in the news release.

Migraines involve severe pulsing or throbbing pain in one part of the head. These intense headaches can also cause people to develop nausea and vomiting as well as sensitivity to light and sound. About one-third of people with migraines experience an aura, or visual effects such as flashing lights, dots or a blind spot, which marks the onset of the headache, said the FDA.

Migraines can last as long as 72 hours if left untreated. These headaches affect 37 million people in the United States. Although anyone — even children — can get migraines, women are affected more often than men, the FDA reported.

“There are many drugs to reduce migraine pain and symptoms,” said Dr. Eric Bastings, a neurologist with the FDA, in the news release. “Although these drugs are quite effective, they are not for everyone. Some can make you tired, drowsy or dizzy. Some can affect your thinking. And some migraine drugs can cause birth defects; so pregnant women can’t use them,” he said.

The Cerena Transcranial Magnetic Stimulator can be used as soon as patients feel a migraine coming on. It’s held against the back of the head. After pressing a button, a very short magnetic pulse stimulates the area of the brain that processes visual information, the FDA said.

The Cefaly transcutaneous electrical nerve stimulation device is also FDA-approved as a preventative treatment for migraine. Patients can use this device daily before a migraine develops. This portable, battery-powered device involves an electrode patch that is placed on patients’ foreheads. The patch is connected to a headband. The device sets off an electrical current to stimulate a large nerve in the head that has been linked to migraines, the agency said.

“It’s a set-time therapy — running for 20 minutes and stopping automatically,” Hoffmann noted.

Reported side effects for both devices were minor and resolved quickly, including:

  • Skin irritation
  • Discomfort
  • Sleepiness
  • Dizziness
  • Pain at site of application

The FDA researchers noted the safety and effectiveness of the Cerena and Cefaly have not been evaluated in use by children, pregnant women and those with pacemakers.

More information

The U.S. National Institute of Neurological Disorders and Stroke provides more information on migraine.

Posted: September 2014

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Most Medical Devices Approved for Kids Only Tested on Adults: Study

THURSDAY April 17, 2014 — Most medical devices approved for use in children are not tested on pediatric patients before they are marketed, a new Harvard study finds.

Since Congress passed the Pediatric Medical Device Safety and Improvement Act in 2007, which was designed to stimulate the development of pediatric devices, children have made up only 10 percent of participants in clinical trials, the researchers report.

“Many devices that are approved by the U.S. Food and Drug Administration for use in children have had only very limited study in actual pediatric patients,” said lead researcher Dr. Florence Bourgeois, a pediatric emergency medicine specialist at Boston Children’s Hospital.

“Patients and physicians should be aware of the limitations in the safety and efficacy data of pediatric devices when making treatment decisions,” she said.

Even after a number of regulatory initiatives to increase the number of devices studied and approved for use in children, research on these devices before or after approval remains limited.

“Specifically, we found that in a sample of high-risk devices recently approved for use in children, 84 percent were approved by the FDA without pre-market study in any patients younger than 18 years old,” Bourgeois said.

In the clinical trials supporting FDA approval of the devices in children, less than 5 percent of all participants were younger than 18, she added.

Among the 25 devices the researchers examined, most were heart devices, such as implantable cardiac defibrillators or stents. Others included devices for children with severe asthma or undergoing spinal surgery, Bourgeois said.

“Not only were many of these devices tested in limited pediatric populations, but many were also approved on the basis of clinical trials that did not employ a very rigorous trial design,” she said.

These findings imply that most devices developed by manufacturers for adults are later approved for children despite the limited evidence of their safety and effectiveness in this group, Bourgeois said.

“Future efforts to increase the availability of medical devices to pediatric patients should insure that devices are adequately studied in pediatric patients both in pre-market and post-marketing studies,” she said.

The report was published online April 14 and in the May print issue of Pediatrics.

One regulatory agency representative pointed out a different problem: Few new devices are being developed that are specifically intended for children.

FDA Spokeswoman Susan Laine said, “It’s important to note that the study referenced included very few devices indicated for pediatric populations younger than 18 years of age. This underscores the challenges of not only evaluating products for these younger populations, but also getting companies to invest in product development for these age groups.”

FDA evaluates all devices for safety and effectiveness based on the indications and data provided by the sponsor, Laine said.

“Because of the small populations involved in pediatrics, many devices may be approved by the Humanitarian Device Exemption pathway, which provides an alternate marketing path if certain criteria are met for rare conditions,” she said. “The FDA considers flexible and adaptive clinical trial designs when reviewing devices in any small population. Additionally, the FDA takes into consideration the availability of alternative treatment options.”

For the study, the researchers looked at the pre- and post-market testing of devices the FDA considers Class III, or high risk.

Bourgeois’ team found that of 22 devices approved for use in kids, 88 percent were only being tested on adults 18 and older. This was possible because the FDA Center for Devices and Radiologic Health considers patients between 18 to 21 to be children, the researchers noted.

Most of the devices approved were not tested in randomized trials — which are considered the gold standard for clinical trials.

Although the FDA required post-marketing studies of 19 devices once they were in clinical practice, only three required testing on children, the researchers noted.

One expert said the new findings did not come as a surprise.

“This is something those of us in pediatrics have known for a long time,” said Dr. Michael Duchowny, a pediatric neurologist and director of academic affairs at Miami Children’s Hospital Research Institute.

“It’s not just with devices, but with medications as well. About 80 percent of the medications we prescribe have never undergone clinical trials in children,” he said. “There are inadequate trials for devices and medications in children.”

The effect is a lack of data on devices and drugs used for children, Duchowny said.

Often drugs and devices are used “off label” in children, he said. Duchowny believes the FDA should give companies incentives to test their drugs and devices in children.

More information

For more about medical devices, visit the U.S. Food and Drug Administration.

Posted: April 2014

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Drugs.com – Daily MedNews

Release of highly anticipated ceramic smoking devices hinges on court battle


hiveceramics.jpg
HiveCeramics.com

One of the most talked about new brands at the American Glass Expo (A.G.E.), held this past January in Las Vegas, was HIVE Ceramics and their gleaming white depictions of everyday dabbing tools typically made from quartz or titanium. Domeless ceramic nails in all sizes, glossy white ceramic “Flower Bowls”, dabbers, hash screens, and, of course, they figure you must have the “HIVE Medical Grade Ceramic Carb Cap w/ Dabber”.

For all the publicity that the new product cultivated, from the A.G.E. show in January to a targeted social media marketing campaign, nobody seemed to know where to get one, or anyone who had actually tried one. For every new fan of the brand, or “Like” on the Facebook page, there have been an equally growing number of skeptics who can’t help but wonder what has happened to all the hype.

A likely reason for the fizzled launch is that the current ownership of the trademarked name HIVE is under dispute, and is now heading to court in a case full of accusations ranging from breach of contract, to outright slander.

Wael “Wally” Sakallah is a pipe maker in Minneapolis, Minnesota. He too has a ceramic pipe, of sorts, already being sold under the name “Hive”, though his product does not enjoy a fraction of the pent-up popularity as the HIVE Ceramics products unveiled at A.G.E.

Sakallah was allegedly there at the event, in Vegas this past January, to meet with HIVE Ceramics to supposedly finalize an agreement that had been in the works since December of 2013. HIVE Ceramics is owned by a publically traded company called Vape Holdings, and it was Vape who had negotiated a deal with Sakallah late last year in which they claim that Sakallah agreed to release the trademarks on the “Hive” name to Vape Holdings for the sum of $ 50,000.

Vape says that at the A.G.E. show in January, Sakallah told Vape’s president that he was already in the process of removing the Hive name from all of the work that came out of his Stone Arch Studios, and they say, he pressed the company for payment on their agreement.

Vape Holdings then proceeded to send Mr. Sakallah copies of all applicable paperwork from the U.S. Patent and Trademark Office, as well as a check for $ 50,000. Sakallah reportedly never cashed the check, never signed or returned the documents, and according to Vape, is attempting to back out of his agreement in hopes of renegotiating for a higher payoff.

That is their story, and they are taking it to court, accusing Mr. Sakallah of breaching their contract and then tarnishing the HIVE Ceramics brand in the marketplace by calling their name into question in public forums. Besides that, they probably have a shitload of ceramic sitting on the shelf right now, awaiting a conclusion to this dispute.

The 14-page complaint goes a little like this, “Plaintiff Vape is forced to bring this lawsuit because Stone Arch, and its principal, Sakallah, suffer from ‘seller’s remorse. This remorse comes after Sakallah later learned that Vape is a publicly traded company, and an up and coming leader in the legal cannabis industry, which plans to produce high-intensity, vaporization element systems (‘H.I.V.E.’), a ceramic vaporization piece. That is, Stone Arch and Sakallah seek to extort more money from Vape than the previously agreed on sales price based on their post-sale inquiries regarding Vape’s financial position.”

So, in return, Vape is asking the court to force Sakallah and Stone Arch Studios to cease all use of the trademarked name “Hive”, and to release it to them. Oh, and they want one million dollars for their time and reputation spent.

The matter rests now in the Federal Court system. In the meantime, the marketplace of innovation-hungry cannabis connoisseurs will have to settle for what’s been working just fine.

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‘Talking’ Medical Devices, Apps Continue to Evolve


‘Talking’ Medical Devices, Apps Continue to Evolve

Innovations can help people manage their conditions, function in emergencies, keep doctors informed

WebMD News from HealthDay

People with left-brain dominance tend to listen

By Mary Brophy Marcus

HealthDay Reporter

TUESDAY, Feb. 18, 2014 (HealthDay News) — They remind you when it’s time to take your medicine, coach you through emergency medical procedures and text you their approval when you eat your veggies.

No, they’re not mothers or nurses or family doctors — they’re “talking” medical devices and apps, among other techy health-focused inventions, that help people manage everyday wellness routines, such as taking pills and checking blood sugar levels, as well as dire medical circumstances.

Talking medical device technology isn’t new, but more and more device makers are using the technology now to create more patient-friendly products, said Benjamin Arcand, an engineer and product innovator in the medical devices field, and associate director of the innovation fellows program at the University of Minnesota’s Medical Devices Center.

Talking portable defibrillators have been around for years, guiding users through the steps of saving a cardiac arrest victim. A new epinephrine pen follows suit — it calmly instructs a nervous parent or teacher through the injection process to help stop an allergic child from going into anaphylactic shock.

Other high-tech health tools help teach operating room staffers how to assemble the complicated set-ups of rarely used surgical devices. In homes, chatty thermometers tell parents a child’s fever reading and an innovative new app lets an expectant mom hear a baby’s heartbeat.

“People have been thinking about talking devices for a long time. The technology has been trying to rise up above the surface for a long time,” Arcand said. Finally, he said, the technology is sophisticated enough and affordable enough.

“What I think you’ll see is user-friendliness is going to go up over time,” Arcand said. “About 10 or 20 years ago, we saw this huge bloom of all these medical devices. Now that the industry is maturing and there’s more regulation and less funding capital, new device development is slowing down.”

He said while the pace of new products entering the market has slowed, better, more updated versions of older ideas are appearing: voice-prompting and voice-activated devices, and better electronic interfaces for patients, and devices talking to other devices.

“More incremental improvements, not so much breakthrough devices,” Arcand added.

He said some inventors of talking medical devices, including himself, employ “ethnographic” research so their inventions will be more likely to succeed right out of the starting blocks, and avoid expensive redesigns or worse, injuring patients.

With ethnographic research, “an inventor might go into the operating room and see how staff uses a device and talk to them about it,” Arcand explained. “There will be observation and interviewing. It’s about careful observation and watching what happens over time and throughout the patient’s care and recovery.”

Bernard Fuemmeler, an associate professor of community and family medicine at Duke University Medical Center, said a glut of health apps “talk” back, too.

WebMD Health

FDA Launches System to Label Medical Devices

FRIDAY Sept. 20, 2013 — A new system that provides unique labels to identify medical devices is being instituted by the U.S. Food and Drug Administration.

Called the unique device identification system (UDI), it will potentially improve the ability to identify devices that malfunction or cause harm to patients, enable faster targeted recalls and improve patient safety, agency officials said Friday.

“UDI may be an acronym for a unique device identification system, but what it really stands for is better information, better access to safe and effective medical devices, and, ultimately, better patient health,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a late-morning press briefing.

This is a new way to identify medical devices throughout their distribution and use, he said. “Many medical devices will be required to have a code on their label, packaging or the product itself in plain text and machine-readable format — like a barcode,” Shuren said.

The system includes two parts. First, each device will be assigned a unique identification code number. “The code identifies the model and version of the device and provides production information such as lot number and expiration date,” Shuren said.

Second, the FDA will establish the Global Unique Device Identification Database, which will be a catalog of every device with an identifier. This database will be accessible by the public, but no patient-identifying information will be stored in the system, the agency said.

The unique device identification system will be phased in over time with so-called high-risk devices (Class III) the first to be listed. These devices include implanted pacemakers, defibrillators, artificial joints, heart valves and heart pumps.

Many devices considered low-risk will not have to be listed at all, according to the FDA.

When complete, the system is expected to benefit patients, the health care system and the device industry, the agency said in a news release.

The system will make it easier and faster to identify devices being recalled, improve the accuracy of reports of problems with devices, and provide a way to spot counterfeit devices, according to the FDA.

In addition, the system will make it easy to trace the use of devices in electronic health records and medical-information systems.

“We did this so that it would be easy to eventually link the use of a device with the patient’s experience with that device,” Shuren said.

This could be a valuable clinical resource, for assessing the benefits of medical devices in real-world use, “which will support not only safety, but innovation,” he said.

High-risk medical devices will be required to have unique device identifiers within one year, and the number and device information must be included in the new database.

For most Class II devices, such as powered wheelchairs, joint prostheses and infusion pumps, manufacturers will have three years to comply. For Class I devices not exempt from the rule, manufacturers will have five years, the agency said. Class I devices include items such as bandages, exam gloves and tongue depressors.

More information

For more about medical-device safety, visit the U.S. National Library of Medicine.

Posted: September 2013

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Drugs.com – Daily MedNews

Is Excessive Usage Of Your Digital Devices Causing “Digital Dementia”??

microscopes 3 150x150 Is Excessive Usage Of Your Digital Devices Causing Digital Dementia??Doctors of the Balance Brain Center in Soul, Korea have discovered deterioration in cognitive abilities among humans that is normally only associated with individuals that have contracted a brain injury or are suffering with a psychiatric illness. The cognitive deterioration in question is apparently due to the over usage of digital devices such as smart phones.

That’s right, America, it’s time to take a break from tweeting your brains out (not from surfing The 420 Times) before you cause self-inflicted, early onset dementia!

IPad 3 Is Excessive Usage Of Your Digital Devices Causing Digital Dementia??

Be careful and use me in moderation! You might get emotionally distressed and forget how to operate me!

The study shows that people who use their tablets, mobile phones and etc., for more than seven hours daily show a substantial lack of development in the right sector of their brain, which is the side that is responsible for concentration and, wait, what was I writing about? Oh yeah, memory.

The doctors claim the side effects of prolonged digital device usage could lead to emotional complications, and as we mentioned before, early onset dementia.

Oy vey, wait until the gang over at Apple hears about this latest development….lol…like this story will scare anyone off their digital dependency. Just keep making those devices, we’ll keep using them. We ain’t skeerd! Well, maybe a little.

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