Replies to post #842 on Accuray Inc (ARAY)

[grantg2]

plfm... HOW OLD is that google blog thread you discovered

& quoted?

It is quite easy to resolve the confusion that post caused for you...

first, it is unlikely that Medicare or insurance would be covering treatment by a technology UNAPPROVED by the FDA...

second, it is unlikely that an unapproved technology would already have so many units sold overseas and in the USA...

(unapproved technologies usually have a few "investigative devices" approved and located at the most cutting edge clinics & hospitals doing the research for that very approval)...

finally, the answer to your question can be advance googled:

first line = CyberKnife
second line = FDA approval

yields 10 pages of hits...

some of the hits:

But until the recent broadened FDA approval of the CyberKnife, stereotactic radiosurgery was not widely used outside the head and neck area because other...

http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Precise_Radiation_Tool_Approved_for_Broader_Use.asp

CyberKnife radiosurgery centers are being established worldwide; the first such center is here at Stanford. Recently the CyberKnife received FDA approval to ...

http://med.stanford.edu/neurosurgery/patient_care/radiosurgery_cyberknife.html

Some of the articles are relevant, some are not. Some are put out there by the competition in defending their own devices versus CK. It pays to read much once you have done a google search on anything, and it pays MORE to filter everything the search turns up carefully because the internet is the "old west" and all kinds of FALSE information co-exists with the true information available. Also the internet data is forever... very old information exists and is often found sooner than the most recent updates related to the topic you are searching.

I did not check the company website... but I'd almost wager that information related to FDA approval can be found there as well. Probably exact dates of the approvals for expanded protocols are available. IF not, I'm sure IR could provide them is requested.

Point is, the first FDA approvals date back to the late 1990s so the blog snippet you posted must be about 10 years old. If you could have confirmed such an old date on it, that alone would have told you that CyberKnife has moved well beyond that comment.

Also, the company states that there have been over 45,000 patients treated globally with CK... that seems a bit larger sample of patients than would be required to complete ANY Phase III trial to verify the technology although I did not actually find/read documents related to Phase III testing in posting this information.