Latest news with #FDA-approved
Perth Now
4 hours ago
- Health
- Perth Now
Alarm sounded over anti-choking devices installed in Perth
The son of the doctor credited with the development of the Heimlich manoeuvre says there are risks from using anti-choking devices to save people's lives. Brian Bwoga, of Beldon, has been asking councils across Perth to install LifeVac anti-choking devices after his 22-month-old son Zaza died after choking on a grape in 2024. The Town of Bassendean is the latest council to consider his request. The cities of Joondalup and Vincent agreed earlier this year to install the devices. LifeVac is a self-powered portable suction device developed for clearing the upper airway when standard first aid protocols fail to relieve a choking incident. But Philip Heimlich says his father Dr Henry Heimlich, who died in 2016, said the drawbacks of such devices were 'obvious', including that they had to be nearby and it would be 'virtually impossible' for victims to use it on themselves. While he admired the councils' dedication to saving lives, Mr Heimlich said in an email to the Joondalup and Bassendean mayors that studies had shown the dangers of anti-choking devices. The contents of the Lifevac kit. Credit: Supplied The Royal Life Saving Society WA Inc has said there was limited evidence of efficacy of the anti-choking devices and was concerned they could cause additional harm if not used appropriately or delayed the use of established procedures. The US Food and Drug Administration choking rescue protocols do not include anti-choking devices as they have not been FDA-approved or cleared. 'Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols,' its website says. Mr Heimlich said people could suffer brain damage or death in four minutes if the choking object was not dislodged. 'Since my father invented the Heimlich manoeuvre in 1974, untold numbers of choking victims have been saved by his procedure around the world,' he said. 'Each week, there are dozens of news reports on lives saved by his method, and it's extremely rare that the Heimlich manoeuvre is not effective.' A Heimlich manoeuvre involves a person standing behind a person and squeezing their diaphragm. The American Red Cross and UK National Health Service recommend abdominal thrusts only if coughing and slaps to the back do not remove the obstruction. They are not recommended on children younger than one year old. Mr Bwoga told the Town of Bassendean's June 24 meeting about 10 WA councils had agreed to install the devices and they cost less than $200. 'I'm not here to make somebody vote for something they don't wish to vote for but I'm just here as a dad who's trying to make sense out of this tragedy,' he said. 'I don't want to hear another parent go through the same thing that I went through.' The council voted in support of mayor Kath Hamilton's proposal that the town investigate the costs, benefits and risks of installing LifeVac devices at town facilities where automated external defibrillators are installed and report back by August. Town CEO Cameron Woods said it was always prudent to do some research but 'cost is not an issue when we're talking about saving young lives'.
Miami Herald
4 hours ago
- Health
- Miami Herald
Elon Musk's brain chip was put in a patient at Miami-area hospital. What to know
A paralyzed military veteran is one of seven people in the country — and the first patient at a Miami hospital — to be implanted with an Elon Musk-backed brain chip as part of a clinical trial underway in South Florida. The goal is to test whether the chip, created by Neuralink, a company co-founded by Musk, can give people who are paralyzed the ability to use their mind to control computers, smartphones and other electronic devices. Surgeons at the University of Miami Miller School of Medicine implanted the device, known as the Link or Telepathy, in the patient's brain as part of the FDA-approved clinical trial. And so far, the tech seems to work. Video recently shared by UM shows the veteran, who was only identified as RJ, using his mind to wirelessly play a video game on a computer. Photos posted online also show Musk making the 'U' sign in celebration with UM medical staff at the hospital. 'They're giving me my spark back … my drive back. They've given me my purpose back,' RJ said in a statement. RJ, who has a spinal cord injury stemming from a motorcycle accident, received the Neuralink implant in April at UHealth Tower, the Miami flagship hospital of the University of Miami Health System. As of last week, RJ was one of seven people in the country who have received the Telepathy implant since clinical trials began last year, according to Neuralink co-founder and president DJ Seo. He's also the first patient to get the implant through The Miami Project to Cure Paralysis at UM's medical school, which was tapped earlier this year to be the second site in the country to test the safety and effectiveness of the chip. The first patient, Noland Arbaugh, had his Link surgically implanted last year at the Barrow Neurological Institute in Phoenix. 'We're very cautious with Neuralink in humans' and are working closely with regulators, Musk said during a June update on Neuralink's progress creating devices that improve or restore movement, vision and speech. 'That's the reason we're not moving faster than we are, is because we're taking great care with each individual to make sure we never miss and, so far, we haven't.' READ MORE: What's it like to use Elon Musk's brain chip? How does it work? 'Like using the Force' For the Telepathy trials, researchers are looking for volunteers 22 to 75 years old who have limited or no ability to use both hands to participate in the clinical trial. The paralysis must be from a cervical spinal cord injury or from ALS, a rare disease with no cure that causes nerve cells to stop working and muscles to become weak, leading to paralysis. Neuralink has also received approval to launch similar trials in Canada, the United Kingdom and United Arab Emirates, according to Seo. 'We hope this partnership is another significant step in finding meaningful solutions for the millions living with paralysis and other significant motor deficits,' Marc Buoniconti, president of The Miami Project to Cure Paralysis and the son of the late Miami Dolphins linebacker Nick Buoniconti, previously told the Miami Herald. Marc Buoniconti became a quadriplegic following a spinal cord injury while playing in a 1985 college football game. His father helped establish the Miami Project. And unlike other types of brain surgeries, the surgical implant of the Link is not as invasive, according to Dr. Jonathan Jagid, UM's principal investigator for the clinical trial and part of RJ's surgical team. How does Neuralink's brain chip work? Surgeons made a relatively small incision to implant a wireless, rechargeable coin-sized brain chip in the part of RJ's brain that handles thoughts and body movement. A Neuralink surgical robot with a needle that's thinner than a human hair is used to implant more than 60 flexible ultra-thin 'threads.' The threads are so fine that they can't be inserted by human hand, according to Neuralink. 'The surgery went perfect,' Jagid told the Herald in a phone interview this week while discussing RJ's procedure. The veteran was discharged from the hospital a day after his surgery, he said. The device records electrical signals sent between brain cells and wirelessly transmits it to Neuralink's software, which will be running on a computer or another device. The software will then decode and translate the neural data into actions, such as moving a cursor or a chess piece on a computer screen, playing video games and even using design software. Neuralink is also testing whether its brain chip can help patients control a robotic arm. 'I think my favorite thing's probably [being] able to turn on my TV, like the first time in two and a half years I was able to do that. That was a pretty sweet move,' RJ said during a recorded video call with several other Telepathy users. The recording was played during Neuralink's June 27 event. RJ, who identified himself as the fifth person in the country to receive the Link, was also shown playing Call of Duty and Mario Kart with the other Neuralink patients. All of it was done wirelessly using their minds. 'I like shooting zombies. That's kinda nice,' said RJ, whose shirt read: 'I do a thing called whatever I want.' For Jagid, the UM doctor, the technology is a step in the right direction for The Miami Project's mission to find a cure for paralysis from spinal cord injuries and help improve patients' quality of life. And RJ's involvement in the trial will help 'move the science forward in order to help everybody else who suffers with these types of injuries,' he said.
Business Insider
19 hours ago
- Business
- Business Insider
Novo Nordisk, WeightWatchers expand collaboration
WW International (WGHTH) 'announced an expanded collaboration with Novo Nordisk (NVO), which includes increased access to authentic, FDA-approved Wegovy injection through WeightWatchers (WGHTQ) Clinic. As the only holistic platform focused on long-term weight health featuring the No. 1 doctor-recommended weight loss program included in the recently announced collaboration with Novo Nordisk, WeightWatchers continues to reinforce its role as the trusted leader in sustainable, science-backed weight care, and one of the few in the industry to publicly commit to prescribing only FDA-approved medications. As part of the collaboration, WeightWatchers Clinic members will benefit from a simplified prescription process via NovoCare Pharmacy. CenterWell Pharmacy, a seven-time MMIT Specialty Pharmacy Patient Choice Award winner for best-in-class customer satisfaction and commitment to patient care, serves as the dispensing pharmacy for the NovoCare program and will facilitate direct fulfillment and home delivery of Wegovy prescriptions for WeightWatchers Clinic members. In addition, WeightWatchers will enhance the member experience by providing integrated account access, bundled pricing opportunities, inventory visibility, and shipment tracking. Additionally, Novo Nordisk is offering a limited-time savings offer available to WeightWatchers Clinic members. Starting July 1, 2025, eligible cash-pay members can access Wegovy at a reduced price of $299 until July 31, 2025-a significant savings aimed at expanding access to clinically validated, FDA-regulated treatment options.'
Time Business News
21 hours ago
- Health
- Time Business News
Plasma Pen: The Non-Surgical Revolution in Skin Rejuvenation
In the world of advanced skincare and aesthetic treatments, the Plasma Pen is making waves as a revolutionary non-invasive solution for skin tightening, lifting, and rejuvenation. With its ability to stimulate collagen production and improve skin texture without surgery, become a go-to treatment for those seeking youthful, smoother skin without the risks and downtime of traditional procedures. In this in-depth blog, we'll explore everything you need to know about what it is, how it works, who it's for, benefits, potential side effects, and what to expect during and after treatment. A Plasma Pen is an FDA-approved device used in aesthetic medicine to perform fibroblast therapy, a skin-tightening and lifting treatment. The device uses plasma energy, created by ionizing the gas in the air between its tip and the skin surface, forming a small electrical arc. This arc creates controlled micro-trauma on the skin's surface, triggering the body's natural healing process. The result? Increased collagen and elastin production, which leads to tighter, firmer, and more youthful-looking skin over time. The Plasma converts electrical energy into an electrostatic charge that is transmitted through a disposable probe. When the is brought close to the skin, it ionizes the oxygen and nitrogen in the air, creating a small plasma flash. This arc never touches the skin but creates tiny micro-injuries on the epidermis (outer layer), stimulating the fibroblasts in the dermis to produce new collagen and regenerate tissue. This process: Tightens loose skin Reduces wrinkles and fine lines Improves skin texture and tone Promotes natural healing The Plasma Pen is versatile and can address a wide range of skin concerns, including: Fine lines and wrinkles Crows' feet Droopy eyelids (non-surgical blepharoplasty) Forehead lines Smile lines Neck lines (turkey neck) Stretch marks Scars and acne scars Age spots and pigmentation The device is most commonly used on the face and neck, but it can also be used on the abdomen, knees, and other parts of the body. Benefits of Plasma Pen Treatment No incisions, no stitches, and no general anesthesia required. It's a perfect option for people seeking an alternative to surgical lifts and tucks. While there's some temporary redness and scabbing, the recovery is relatively short, typically 7–10 days compared to weeks for surgery. The results develop gradually over several weeks as collagen rebuilds, giving a more natural and subtle enhancement. With proper skin care, results can last 2–3 years or more. Maintenance treatments may be performed as needed. Trained practitioners can precisely target problem areas without affecting surrounding tissues. Ideal candidates for Plasma Pen treatment are individuals who: Are in good general health Have mild to moderate skin laxity Are non-smokers Have realistic expectations Are not pregnant or breastfeeding People with darker skin tones may need to consult with their provider about the risks of hyperpigmentation or hypopigmentation, as plasma treatments can occasionally affect melanin. Your provider will assess your skin, discuss your goals, and determine if the Plasma Pen is the right treatment for you. Topical numbing cream is applied to ensure comfort during the procedure. This is typically left on for 30–60 minutes. The Plasma Pen is moved across targeted areas, creating a series of tiny dots (carbon crusts) where the plasma energy comes into contact with the skin. The session typically lasts 30 to 90 minutes, depending on the treatment area. You'll receive detailed aftercare instructions. Swelling and redness are common for the first few days, followed by the formation of small scabs. These crusts naturally fall off within a week. Do not pick at the scabs. Allow them to fall off naturally to avoid scarring. Allow them to fall off naturally to avoid scarring. Avoid direct sun exposure for at least 2 weeks. Use SPF 50+ daily. for at least 2 weeks. Use SPF 50+ daily. Skip makeup until your provider gives you the all-clear. until your provider gives you the all-clear. Use only recommended products to soothe and hydrate the skin (usually a healing balm or cream). to soothe and hydrate the skin (usually a healing balm or cream). Avoid hot showers, saunas, and excessive sweating during the first 7–10 days. Initial tightening may be noticeable within a week, but full results typically develop over 8 to 12 weeks as collagen regenerates. Many patients require only one session, while others may benefit from two or more treatments spaced several weeks apart. When performed by a certified and trained professional, it is considered safe. However, like any aesthetic procedure, there are potential risks: Swelling and redness Scabbing or crusting Hyperpigmentation or hypopigmentation Infection (rare) Prolonged healing occurs if aftercare is not followed Always choose a reputable provider with experience using the Plasma Pen device. Treatment Invasiveness Downtime Results Duration Cost Plasma Pen Non-surgical 7–10 days 2–3 years Moderate Botox Non-surgical Minimal 3–6 months Low to moderate Microneedling Non-surgical 1–3 days 6–12 months Low Surgical Facelift Invasive 3–4 weeks 5–10 years High The Plasma Pen bridges the gap between injectables and surgical procedures, offering a cost-effective alternative with long-lasting results. Conclusion: Is the Plasma Pen Right for You? If you're looking for a powerful, non-invasive way to rejuvenate your skin, tighten problem areas, and reduce signs of aging, the Plasma Pen could be the ideal solution. With its ability to stimulate collagen naturally, this treatment provides long-term benefits without the risk and downtime of traditional surgery. Whether you're considering treatment for fine lines around the eyes, loose skin on the neck, or acne scars, always consult a licensed aesthetic provider for a personalized recommendation. Further, for more, you can donate freedom plasma Ready to reveal younger, firmer skin? The Plasma Pen might be your secret weapon. TIME BUSINESS NEWS
Time Business News
a day ago
- Health
- Time Business News
Fibroblast Plasma Pen: A Non-Surgical Solution for Skin Tightening
In the world of advanced skincare and cosmetic treatments, non-invasive solutions are rising in popularity as people seek effective results without the risks and downtime of surgery. One device at the forefront of this aesthetic revolution is the Fibroblast Plasma Pen . Designed to tighten, lift, and rejuvenate the skin, the Fibroblast Plasma Pen offers a safe and effective alternative to surgical procedures like eyelid lifts and facelifts. This blog will guide you through everything you need to know about the Fibroblast Plasma Pen—what it is, how it works, who it's for, its benefits, potential side effects, and what to expect during and after treatment. The Fibroblast Plasma Pen is a non-invasive skin tightening device used in aesthetic medicine to treat signs of aging and skin laxity. It works by delivering controlled plasma energy (ionized gas) to targeted areas of the skin, creating micro-trauma that stimulates fibroblast activity. Fibroblasts are collagen-producing cells in the dermis responsible for skin firmness and elasticity. When activated through plasma therapy, they accelerate tissue regeneration, resulting in smoother, tighter, and more youthful-looking skin. The device is FDA-approved in many regions and widely used by trained estheticians and medical professionals. The treatment works through a process called Plasma Fibroblast Therapy. Here's how it functions: The pen creates a small, controlled arc of plasma (ionized gas) between its tip and the skin's surface. This arc causes tiny micro-injuries (also known as carbon crusts or dots) on the skin. These micro-injuries trigger the body's natural healing response, stimulating fibroblasts to produce collagen, elastin, and new skin cells. Over the following weeks, this cellular activity leads to tighter, firmer, and rejuvenated skin. Importantly, the pen never touches the skin—the energy discharge occurs just above it, minimizing the risk of deeper tissue damage. This versatile device can be used on a wide range of facial and body areas, including: Upper and lower eyelids (non-surgical blepharoplasty) Forehead lines and frown lines Crow's feet Nasolabial folds (smile lines) Neck and décolletage Jawline tightening Acne scars Stretch marks Sunspots and age spots Loose stomach skin (postpartum or post-weight loss) There are several reasons why patients and skincare professionals are choosing the Fibroblast Plasma Pen over traditional surgical options: No cutting, no stitches, and no general anesthesia are required. It's ideal for those who want significant results without the risks and cost of surgery. Since the treatment works by stimulating your body's natural collagen production, the results appear gradually and look subtle and natural. Most patients experience mild swelling and scabbing that resolves in about 7–10 days, significantly less than surgical recovery times. Depending on skin condition and lifestyle, results can last between 2 to 3 years. Maintenance treatments can extend the benefits. The pen can treat everything from small fine lines around the eyes to larger areas of sagging skin on the body. You may be a good candidate if you: They are generally in good health Have mild to moderate skin laxity or wrinkles They are not prone to keloid scarring Are not pregnant or breastfeeding Have realistic expectations about non-surgical results Note for darker skin tones: Plasma Pen may carry a higher risk of hyperpigmentation or hypopigmentation for Fitzpatrick skin types IV–VI. A patch test or alternative treatment may be recommended. A trained provider will assess your skin, medical history, and treatment goals to determine if Plasma Pen is appropriate. A topical numbing cream is applied and left on for about 30–45 minutes to minimize discomfort during the procedure. The practitioner applies the Plasma Pen to the skin, creating a series of tiny brown 'carbon crust' dots. Treatment time varies but typically takes 30–90 minutes, depending on the area. You'll receive detailed aftercare instructions. Swelling and redness are normal for the first 1–3 days, followed by scab formation that naturally falls off within a week. Proper aftercare is crucial for optimal results and preventing complications: Do not pick or scratch the carbon crusts; allow them to fall off naturally. the carbon crusts; allow them to fall off naturally. Keep the area clean and dry for the first 24 hours. for the first 24 hours. Avoid direct sun exposure for at least 2 weeks; wear SPF 50+ daily. for at least 2 weeks; wear SPF 50+ daily. Use only recommended soothing creams and avoid makeup until healed. and avoid makeup until healed. Avoid vigorous exercise, saunas, and swimming for at least a week. While Fibroblast Plasma Pen is considered safe when performed by a trained professional, some potential side effects include: Swelling and redness Itching or tenderness Temporary pigmentation changes Infection (rare, with improper aftercare) Scarring (very rare, usually if crusts are picked off) Always choose a qualified provider to minimize risks. You may notice some tightening immediately after treatment, but full results develop over 6–12 weeks as collagen production continues. For some conditions, such as deeper wrinkles or significant skin laxity, a second or third session may be recommended. Treatment Invasiveness Downtime Results Duration Target Concerns Fibroblast Plasma Pen Non-invasive 7–10 days 2–3 years Wrinkles, sagging, eyelid lift Microneedling Non-invasive 2–3 days 6–12 months Texture, scarring Botox Non-invasive Minimal 3–6 months Expression lines Surgical Facelift Invasive 3–4 weeks 5–10 years Severe sagging, jowls If you're looking for a non-surgical, effective, and safe way to rejuvenate your skin, the Fibroblast Plasma Pen could be the solution. It provides visible improvements in skin texture, tone, and tightness with minimal risk and downtime. Whether you're aiming to lift droopy eyelids, reduce fine lines, or refresh your skin without surgery, Plasma Pen treatment offers impressive results backed by science and loved by clients worldwide. Book your consultation today and take the first step toward smoother, tighter, more radiant skin—naturally and non-invasively. TIME BUSINESS NEWS
