Having known Anna for about 4 years and Peter for at least 40 years and having asked many questions, I feel I can shed some light on the FDA situation as well as the many questions that people (shareholders) have, and clarify some doubts about countries where Meridian is selling their product.
Please do not bombard me with more questions, because I’m in no position to answer or elaborate any further on the topics that I posted.
Meridian has filed a 510k submission with the FDA. This submission was accepted, but FDA required an efficiency test.
The test was submitted, and proved that Meridian was correct in what the company claimed the equipment would do.
The test was submitted by Dr. Greenway.
The FDA did not accept this test and came back with the following deficiency claim.
They require a test based on the ethics of the equipment. Upon the advice of Meridian’s lawyer, Peter Hutt, they inquired as to the reason for this test when it was already approved for carpel tunnel syndrome and muscle pain.
It seems they lost that fight, and it would have taken the lawyer another year to fight it.
Meridian decided to give them the test they wanted. The test is an Ethics test and is presently underway.
The competitive products that are mentioned in advertisements, as well as posted on this board, who claim to have FDA approval, are based on radio frequency that can reduce the appearance of cellulite temporarily by rubbing the skin, almost like ironing fabric.
Similar products, some of which have FDA approval, and say they are non invasive, actually are lipo suction, breaking down fat. This is an invasive procedure.
The integrity of Meridian is based on similar standards the FDA requires. This warrants Meridian to thoroughly research all the challenges that have been brought to their attention. It is a necessary action in order to provide patients with the most accurate results.
Credo
