"The book is directly tied to the Hypoxia platform technology which uses the MDX Viewer as an analytical method, which is an FDA approved device to measure tissue oxygenation. "
You said:
He is head of MDX Life Sciences which has developed the MDX Viewer and is seeking FDA approval for the device. You shouldn't spread misinformation.
"MDX Viewer as an analytical method, which is an FDA approved device to measure tissue oxygenation. The device measures the consumption of oxygen molecules in tissues on a cellular level.
The output of the MDX Viewer is the Brain Metabolic Score BMS, which is a vital part of the approval process for Bioxytran’s acellular oxygen carrier (AOC) molecule called BXT-25. Bioxytran plans on using the BXT-25 in its clinical trials for ischemic stroke and Alzheimer’s disease patients as a way to replace hyperbaric oxygen treatment (HBOT).
Macchio is correct. From MDX website (notice the vague answers--tricky wording on several items on website??)
Q. WHAT IS THE REGULATORY STATUS OF THE DEVELOPED MEDICAL DEVICE?
A. MDX Life Sciences is capable to provide a FDA approved device that will monitor 4 physiological parameters from tissues of patients in real time. The TMS will need a special approval by the FDA.