Bioelectronics Corp (BIEL)

[ddls]

The FDA registers items, and the FDA approves items. Do not confuse registration with approval. Often, companies tout their system as FDA registered, hoping that the customer will assume that means the same thing as FDA-approved. Truthfully, if a system is FDA registered, that means only that the FDA knows the item is being imported into the US. It is in no way a guarantee of safety or efficacy. All PEMF devices imported into the United States have to have FDA registration. So, no single device is better than another relative to FDA registration. FDA approval and oversight is not necessarily a guarantee of value or safety, either. The FDA approves many drugs that subsequently have to be withdrawn for safety reasons. That being said, there are some FDA-approved PEMF devices, so we know that the FDA does approve of the use of electromagnetic fields for therapeutic use. These are primarily high-intensity PEMF devices like the Neurostar (used to combat treatment-resistant depression).

Furthermore, most manufacturers do not want to be FDA approved. You read that correctly; they are not seeking FDA approval. There are many reasons for this, including the high price tag associated with seeking FDA approval. FDA approval also comes with the stipulation that the product be condition-specific. Because PEMF devices treat us at such a basic, cellular level, choosing only one health condition would be a disservice to both the brand and the consumer. Additionally, PEMF systems are, first and foremost, wellness devices. It is not medication – a magnetic field does not have to be processed by the body like medications do. A magnetic field acts on the most basic of biological functions – the cellular level. It’s more physics than medicine.