Tag: FDA

The Latest In Hair Growth Technology

Hairmax is an FDA-approved at-home laser device for the treatment of male androgenetic alopecia; this form of alopecia is by far the most common source of baldness in males. In order for this laser comb system to be approved by the FDA, it first had to be proven safe and effective; receiving FDA class 2 clearance is no small feat and is a testament to how well the device works. The device has a 90% success rate!

How Does it Work?

Hair growth can be divided into three stages: anagen, catagen and telogen. During the anagen stage, the hair is actively growing in length and is well connected to the dermal papilla, which is a collection of rapidly dividing cells that essentially give life to the hair. Every individual has a different set anagen stage, and this is why some individuals can grow their hair to longer lengths than others; it’s all genetic. After the anagen stage is complete, the dermal papilla recedes and the hair is still firmly rooted but no longer receiving nourishment from the cells; this is the catagen stage. The final stage is the telogen stage and this is the time where hair may begin falling out; ideally the anagen stage will begin again immediately after the hair comes out of the now dried out follicle. When the anagen stage becomes active, the dermal papilla once again provides the hair follicle with the essential nutrients and blood flow for new growth.

Baldness occurs when those follicles begin to shrink in size, leading to the growth of smaller, finer hairs. It is the size of the hair follicle that determines the width of an individual strand of hair. As the follicle gets smaller and smaller so does the hair it produces until finally the follicle is too small to support hair growth at all.

The laser comb stimulates these hair follicles from the root, reviving and restoring their original size. The laser hair growth treatments can even bring completely dormant follicles back to life thanks to the deep penetration of the laser. This is painless, yet extremely effective. Once the hair follicle is restored, the three normal phases of growth will start again.

The red laser increases blood flow to the cells which assists the rapid healing; in addition, the laser also gives energy to the cells which are believed to convert this light energy into adenosine triphosphate. With all of this new energy to use the cells rebuild the hair follicle, returning it to its original state.

How Often to Use

One of the best things about this laser comb is the frequency of weekly use; only three 10-15 minute sessions are required for optimum results. There is no need to be a slave to hair growth treatments anymore.

Positive Feedback and Before and After Results

The positive feedback for this device is astounding with men the world over raving about their results. They consistently report thicker, fuller hair due to the faithful use of the product; they also report other positive side effects such as more shine, vitality and manageability than they ever had before using the product.

Before and after images of actual laser comb users back up these claims with hair that is visibly thicker and a scalp that is much less visible than before. Macro shots of treated scalps also show increased non-vellus hair growth.

FDA Approved

The fact that this device has received FDA approval speaks volumes for its effectiveness. After clinical trials which yielded an amazing 90% success rate, the FDA approved this laser comb as a medical device safe for home use. It is approved to be marketed for male androgenetic alopecia only; however, a number of women have tried using the laser comb with excellent results.

About the Company

The parent company is Lexington International LLC based out of Boca Raton, Florida, and the Hairmax itself is manufactured in the USA under extremely strict guidelines for quality assurance. Lexington International has happy customers in over 125 countries to date.

The Best Smoking Cessation Method – Electronic Cigarettes Vs. Champix

Champix tablets are quite a popular smoking cessation medication that can be bought on a prescription only. An electronic cigarette, on the other hand, works as a nicotine replacement therapy that provides your body with the essential nicotine but without the other harmful additives of cigarette smoke.

Electronic cigarettes are being touted as a safer alternative to conventional tobacco products, such as cigarettes; in addition, they are being marketed as a tool to help you break free from smoking addiction. But mind you, e-cigarettes do contain tobacco and give you an instant nicotine hit that is 10 times faster than gum or patches. On the other hand Champix is completely free from nicotine. It works as a nicotinic receptor partial agonist; this theoretically means that it both stimulates and blocks nicotine receptors to reduce withdrawal symptoms as well as cigarette cravings.

While proponents of electronic cigarettes say that smoking tobacco subjects the users to up to 4,000 different toxins that are released through combustion, electronic cigarettes deliver only nicotine. In fact, a recent U.S. Food and Drugs Administration (FDA) test for carcinogens in e-cigarettes has validated the fact that two of the most popular brands of electronic cigarettes contain toxic chemicals diethylene glycol, nitrosamines as well as other carcinogens which indicate the probability of long term harm. Where as, Champix contains none of these harmful materials; in fact you are evaluated by a medical doctor before you are given the liberty to use Champix.

There are many other concerns raised by health experts which include:

Electronic cigarettes could cause nicotine poisoning; Champix is free from nicotine.
Marketing practices, such as adding chocolate or mint flavourings to the vapour, seem to target teens and children; Champix is strictly a prescription drug and is not recommended for use by children.
People who do not smoke tobacco may become nicotine-dependent after using these safer cigarettes; where as Champix is only prescribed to people who are looking to quit smoking successfully.
E-cigarettes are a largely unregulated product and therefore do not carry product health warnings; where as Champix is FDA regulated and comes marked with all the essential precautionary guidelines.
No studies exist to validate the claim that e-cigarette works for smoking cessation; while Champix was approved for use after sizable clinical trials were conducted.
While e-cigarette is additive, Champix takes you away from nicotine addiction.

Therefore, for the best chances of achieving smoking cessation successfully, you need to combine medication with counseling or support group participation.

Sundries of Clinical Trials That are Much Discarded

The biggest stumbling block to using wearable devices in clinical trials right now is the fact that the majority of devices on the market today are marketed for consumer use, and not approved by the FDA for clinical trial use. In addition, even the most advanced devices may not collect all of the data that researchers need to measure the efficacy of new treatments.

That being said, there are new wearable devices in development specifically for clinical use. While in some cases these devices may appear to resemble the devices we’re all familiar with, many are smaller, more flexible, and more comfortable than consumer devices. The new medical wearables are also more advanced, with the ability to measure blood pressure, fluid levels, and more, giving researchers more insight into patient outcomes — and ultimately, they hope, more accurate results and effective treatments.

The bottom line is that while there are still issues to be worked out, there is great potential for the use of wearable devices in medical trials. With the shift toward electronic data collection, it only makes sense to use technology for more accurate readings — and take the guesswork out of reporting for both patients and researchers. Visit crfhealth.com for more information about clinical trials.

Where Can I Buy Electronic Cigarettes And Smoke Free Cigarette

Sitting in a bar the other day, I noticed that everybody was smoking. However, I live in Chicago and smoking is not allowed inside the bars. So of course I was prompted to find out what this device was. It turns out it was an electronic cigarette. These devices are actually allowed indoors in cities with smoking bans because they are smoke free cigarettes. While there is a puff that looks just like smoke, it is more or less, a water vapor that contains nicotine. So these bar patrons were smoking an electronic cig.

There is no tobacco in this product which also means that it is potentially healthier than a traditional cigarette. While it turns out that this fact hasnt been proven, it certainly would seem intuitive.

Most of the users in this bar recommended that one buy electronic cigarettes online. This is a great way to avoid the outrageous prices you might find at a local store. That of course leads to the question of where can I buy electronic cigarettes, personally? Are there any restrictions based on states or city? And it turns out that while these devices are legal in every state, the FDA is actually seizing shipments that enter into the USA. That seems like a rather strange policy, given that the controversial nicotine can be found in vegetables at your local grocer.

Where to buy electronic cigarettes in some way varies by where you live and how patient you are. If you live here in Chicago for instance, we have some great online retailers but limited high quality products being sold in stores. In Florida not only can products be found in mall kiosks, but the devices can also be found in actual brick and mortar storefronts. However, one should expect to pay a premium when dealing with actual stores in this industry. The best bargains remain those found online.

The quality of these products also varies greatly from distributor to distributor and product to product. There arent many alternatives to this device however. There just arent other smoke free cigarettes. This is a very unique concept and the potential for this product is groundbreaking.

As the people in the bar continued to huff and puff on their e-cigs, I began to wonder just how I hadnt heard of this product sooner! Electronic cigs are definitely something to be excited about. So it seems for those with deep pockets and a lack of patience, the best place to buy electronic cigarettes is at a local retailer. For those consumers with a tendency toward penny pinching and high quality, it seems as though research and an online retailer is your best bet. So while it may seem difficult to figure out where to buy electronic cigarettes, this product is unlikely to disappoint. In fact one retailer noted that despite a 30 day money back guarantee they estimate that they only end up refunding approximately 10% of their consumers. That is an amazing rate and implies that there are many happy users of these products out there in the US.

So if this has left you screaming, Where can I buy electronic cigarettes? get off your butt and go and check out the internet. With many retailers shipping same day and some offering overnight shipping, you could be vaping as soon as tomorrow.

This is seemingly among the most exciting products that has been introduced in a long while. There has been an industry sprout up rapidly throughout the United States, and in a time of rising unemployment and increasing health care costs, this is an actual industry that could help to not only create employment, but also potentially impact healthcare costs in a positive way.

Electronic Adverse Events Reporting What Does It Mean To You

As new regulations and legislation regarding eMDR (Electronic Medical Device Reports) and eMDV (Electronic Medical Device Vigilance Reports) have been forming, medical device companies have been scrambling to get a handle on how exactly to act. Being inundated with lengthy documents and incomprehensible jargon certainly does not make the task any easier. Without a compliance handbook many misconceptions have formed in the confusion and even more companies hardly know where to begin. With a few tips, some shared knowledge and helpful resources, we are here to help.

The first and most important compliance issue deals with reporting MDR information. Unbeknownst to many, every regulatory agency offers their own reporting tools, completely free of cost, and separate from paper submissions. In the US, companies can access the FDAs reporting tool online, enter their MDR information, and electronically submit. Following the submission, the FDA will then acknowledge receipt of the file, and inform you of whether or not it has been accepted. In the event that your data is not suitable, you will then have 30 days to resubmit a revised copy of the MDR information.

Ironically, where in most situations electronic reporting would be preferable to paper submissions from any angle, the FDAs electronic submission system actually requires more work and introduces new opportunities for rejection of the MDR data. In an effort to combat the less than ideal reporting systems regulatory agencies have to offer, companies have begun to implement their own commercial systems to submit MDR information. In many cases these systems have proven effective in reducing risk by generating and submitting compliant reports, and they have in turn cut costs. Paper submission may appear to be a cost effective option but when considering the manpower, time, and lost productivity that it incurs, an eMDR system is typically preferable. Instead of weighing the costs of paper MDR submissions to manual systems provided by regulatory bodies, compare the costs and benefits of regulatory manual eMDR and automated eMDR. The results may be surprising.