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NeoRhythm, from quackery to the best-selling wellness device for non-medical use

NeoRhythm omnipemf

Here’s our story after two years with our clients.

Marko Kadunc, CEO at Omnipemf.

NeoRhythm represents a leading innovation in today’s world of medical and wellness devices, displaying the power of a tested technology in an entirely new aspect. Our initial goal was to create a device to help us relax, offer better sleep and support our meditation practice. In general, these three goals are the three common denominators of our health. PEMF technology displays a variety of such programs, and still reigns as a single entrainment technology to which our body and brain are able to respond to.

NeoRhythm has a bright future, and by incorporating PEMF technology, which straightforwardly acquires several scientific goals, NeoRhythm can offer so much. Besides the myriad of benefits of PEMF technology listed below, recent research has shown remarkable results in treating Alzheimer’s Disease and even post-concussion syndrome treatment. (6,7) 

In the first year of its launch, NeoRhythm was marked as a scam by plenty. But we considered this as quite expected.

Those unfamiliar with PEMF technology or brainwave entrainment mechanism marked NeoRhythm as spam and asserted that we used misleading claims to trick the consumers. We understand that an electronic device with the power to alter our moods may come across as an idyllic idea. But our disposition can also shift by listening to music, natural sounds, light therapy, meditation. How does our brain really differ between reality and commonly believed external stimuli? Similarly, how can a horror movie make us feel scared although our life is not in any immediate danger? 

The truth is that many people, including scientists, do not acknowledge the electromagnetic frequencies virtually every organ and body part emit throughout the day and night. Some highly respected psychiatrists, neurologists (4) will refuse to acknowledge PEMF technology as a wellness system – to aid in relaxation, sleep, or improving meditation practice, but do support PEMF (also known as TMS or tPEMF) for the treatment of depression. Other psychiatrists or neurologists may only recognize chemical treatments, such as drugs, although thousands of medical professionals (5) offer PEMF to be complementary or suggested treatment. Numerous studies (the most representative ones listed on our webpage (5)) prove that PEMF technology, widely recognized as a wellness practice, also offers plenty of other benefits to the medical diaspora. There have been several concluded studies on PEMF benefiting sleep and meditation in addition to depression. But, it is scientifically and clinically proven to work for both.

Different legislation allows for different rules

Here is a short comparison. I will not dive into governmental policies, as I would stray too far away from the purpose of this article, but I feel obliged to begin by saying that the pharmaceutical industry has overtaken our nature. The best way to illustrate this point is the privatization of herbs, which I see as our worldly heritage. The herbs belong to all of us. Herbs have served humanity for thousands of years, yet only seem to benefit us today if they are dehydrated and stuck in a pill. We are not allowed to claim that Chamomile will help you relax or fall asleep or that small-flowered willowherb (Epilobium Parviflorum) can offer support with the treatment of problems with the prostate, kidneys, and urinary tract. In the EU, several laws prohibit writing such benefits on the packaging. How many herbal tea commercials displaying their benefits are there on TV? Close to zero. And although there are several homoeopathic medicines at our disposal that can help us in considerable ways, it seems that wherever the pharmaceutical industry is present, different rules apply to which claims we are allowed to make. Such is also the world where even the PEMF technology is more and more controlled, to which we have to adapt. There is almost no way around it.

NeoRhythm omnipemf

But what is NeoRhythm?

To understand NeoRhythm, we need to be at least vaguely familiar with the PEMF technology and become familiar with its legislative background. It differs from country to country quite significantly, but common to all is that PEMF is swiftly shifting its status from wellness to medical technology. In India, for instance, all PEMF devices are sold as Class I medical devices, whereas, in the US, PEMF is still considered a wellness device.

PEMF technology has a long and fascinating history, and it is one of the most recognized technologies for treating several diseases. The FDA approved PEMF therapy to heal nonunion fractures in 1979 (1) and cleared PEMF for urinary incontinence and muscle stimulation in 1998 (1). In 2004, the FDA approved pulsed electromagnetic field therapy for cervical fusion surgery (1) patients at high risk for non-fusion, in 2006 for the treatment of depression and anxiety (2), in addition to approving PEMF therapy for the treatment of brain cancer (8) in 2006 and 2011. In 2015, the FDA reclassified PEMF machines from Class 3 to Class 2(1) medical devices.

NeoRhythm omnipemf

What is the status of PEMF technology today?

Today, most PEMF devices, especially in the US, are still positioned as wellness devices and therefore readily available to the public. Of course, such classifications differ from PEMF devices that use medical claims, especially for PEMF devices that treat severe diseases (depression) and should be used under the supervision of the professional. 

The legal positioning of PEMF devices also differs from country to country. In the EU, all PEMF devices using medical claims fall under Class 2A medical devices. Unless these devices claim medical use, they are considered wellness devices. With the new MDR regulation (Medical Device Regulation) – MDR, Annex XIV, all devices used directly on the head, should also follow safety and performance standards valid for all medical devices. The new MDR regulation states that equipment intended for brain stimulation applies electrical currents, magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. It is still unclear if the low-intensity devices, like NeoRhythm, directly influence neuronal activity or they only affect the overall brain electrical flows (which are determined by brainwave entrainment mechanism), but at the moment, low-intensity PEMF devices should soon comply with new MDR regulation. It is a fact that low-intensity PEMF devices cannot compare to high-intensity devices due to the different fundamentals of their mechanisms. These devices fire neurons and possess the ability to trigger other body reactions (the Motor Evoked Potential or MEP). (3) These two very different mechanisms remain unspecified in the current legislation (MDR XVI).

With the new medical regulation, all such devices are obliged to follow medical regulations, although they serve non-medical use. Such also applies to NeoRhythm. It is still unclear what this will bring, but one thing is for certain – due to medical device procedures and associated costs, the prices will increase. 

New EU MDR regulation entered into force on the 25th of May 2021, but it is still unclear whether a Notified body will also require the registration of devices for non-medical use. Until now, this procedure was in place for medical devices only. Expecting that the European Commission will release final provisions in March of 2022, we wait for further instructions – NeoRhythm is well prepared for all new regulations. 

In the first part, I described what PEMF is and how it works, but how does NeoRhythm use PEMF technology, and what is brainwave entrainment? PEMF stands for Pulsed Electromagnetic Field. Devices that utilize PEMF technology emit electromagnetic waves at different frequencies to stimulate and encourage our bodies’ natural recovery processes. NeoRhythm emits frequencies that our brain comprehends, and emits on its own throughout the day. The brain is an electrochemical organ. Electrical activity emanating from the brain is displayed in the form of brainwaves. Millions of electrical pulses pass between neurons when we work, exercise, relax, or even sleep. Pulsed Electromagnetic Field technology encourages the brain to mimic signals provided by the device and helps correct any misaligned brain patterns. We can achieve better sleep, relaxation, deep meditation, and focus.

 

NeoRhythm omnipemf

A world where personalization is accessible and affordable is the key to success. 

Our next goal is to completely customize the experience with NeoRhythm and allow for a more personal approach. We are all different, and therefore all products should offer a possibility to be adapted to our own needs, and still be safe and effective. We strongly support that all our clients join the Facebook Community, where professionals, doctors, PEMF enthusiasts, and our customers are free to ask any questions and share their experiences. 

Looking back in the past two years, my understanding of PEMF technology would be that PEMF is an incredibly effective and beneficial technology, but it cannot perform miracles. If we respect our body, PEMF devices can be a great companion and should be with us little by little, every day. 

NeoRhythm omnipemf

What can you do about it?

How to tell when you’re not getting enough deep sleep?

You body will send signals, craving for more Delta time. Insufficient slow-wave sleep can cause a “sleep drive”; throughout the day, you may feel sleepy and fatigued. Your organism will entice you to take a nap, during which your brain will try to get as much deep sleep as possible. Before you ask: no, taking naps won’t solve the problem of deep sleep shortage.

If you want to improve your deep sleep, one of the best ways to do so is to take care of your bedtime routine. Try to make your sleep regular, going to bed at a similar time every night. Most importantly, avoid blue light! Blue light is emitted from the screen of your laptop or phone. Research has shown that it disrupts the secretion of the sleep hormone melatonin. The reason is pretty straightforward: our organisms evolved following the cycle of day and night. When it gets darker, your brain receives it as time for rest. Exposing your eyes to blue light sends the wrong message, confusing the sleep-regulating systems in your brain.

Meditation may help calm down your mind after a stressful day, making it easier to fall asleep. Another solution to help you reach consistent deep sleep includes a PEMF device, which can help to entrain the slow-wave Delta rhythm in our brainwaves.

References

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