It sounds like a good idea.

Here's the regulatory process. If it is deemed a "non-significant risk" (NSR) device then a letter to the hospital (or sometimes private independent clinical investigation contractors) for an internal "Investigational Device Exemption" (IDE), could get clearance to use it in a "beta testing" or clinical trial situation. This is done all the time at teaching and reseach hospitals (it would require prior approval by the "Institutional Review Board (IRB) at the facility. Since it is implantable and introduces energy into the body, it might be considered, by the FDA, to be a "Significant Risk Device" (SRD)(or converesly a new technological advance), in which case, an IDE would have to be filed to and cleared, by the FDA, prior to it's use on human subjects. Because it is an implant, patient contact material biocompatibility safety could also be an issue. I would imagaine the the manufacturer has already done that testing (ISO 10993). Similar devices like TENS units are considered "Class II" and require a 510(k) clearance to market. If this device has no existing predicate device in the market (i.e. a similar device with 510K clearance, then it could well be deemed a "class III" device, requiring a full blown Pre-Market Approval (PMA). This process is lengthly and can take a year or more. It is also very expensive.

"Fast Tracking" through the FDA is only allowed for devices that can have major, provable, life saving benefits. "Quality of life" devices typically to not fall into this category.

There are numerous other side issues - this is a foreign company and compliance issues differ in foreign countries. They would have to be in compliance with US FDA GMP/QSR (Good Manufacturing Practices/Quality System Regulation as well) and prior to the FDA acceptance of a IDE, if a PMA is indeed needed, they would have to request and pass a GMP/QSR audit/inspection by the FDA, at their manufacturing facility. Currently they are not listed in the FDA database as a medical device manufacturer for the US market.

If the device is, in fact, class II or III (which in my professional opinion would be) and it has no FDA clearance to market and/or they are not registered as a medical device manafacturer, then it is considered, by the FDA, to be an "adulterated, misbranded" product. It's use on human subjects here would be clearly illegal. Especially if there is no IDE on file. They would need an FDA approved IDE for clinical studies in the US. They would have to be a registered medical device manufacturer prior to submitting an IDE.

I am a regulatory professionl and just the messenger - so please don't debate me on this. This is ALL factual information and you can click on the link below and see for yourself. I just don't want to give false hope that this will become available simply by emailing to Israel and having them mail you one anytime soon.

Here is a link to the FDA describing, in more detail, the regulatory process for getting device cleared to market.
http://www.fda.gov/cdrh/devadvice/3122.html

Non regulatory issues would be that this device could well be damaged by radiation so it would have to be implanted after radiation, HBO would have to be part of the protocol.