Patient Access Solutions Inc (PASO)

[Roofus]

I’m referring to FDA approval for rTMS.

As I previously mentioned, there is other similar technology that has already been FDA approved (rTMS variance).

The fact that the similar technology was FDA approved doesn't necessarily guarantee FDA approval for the HSTA/PASO rTMS method that will be used, but it does help the cause tremendously, and makes things very straightforward for the FDA.

Here is some background information on what the FDA does and where the HSTA/PASO rTMS patented technology comes into play:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

Of particular interest in practicing the present invention, a patient is subjected to repetitive transcranial magnetic stimulation (rTMS) with variable pulse intervals for a time sufficient to modulate a brain activity in the patient where an improvement in a physiological condition or a clinical condition is achieved. The patient is subjected to an EEG to create an EEG data set. The EEG data set is analyzed with a wavelet transform. The extracted signal by wavelet transform analysis is then used to program the variable pulse intervals (frequencies and amplitudes) into the rTMS apparatus. The wavelet transform algorithm extracts a unique EEG signal and variable pulse interval profile that results in the desired improvements in the physiological or medical condition that is being treated.