Grapefruit USA Inc (GPFT)

[goldcoastoh]

bart ~ on off-label...

dean mentions this in the cc of 12/9/09... wherein he is discussing rewording the intended use statements to more generic statements. wherein he goes on to say that, as par for the course, so to say, it is typical to finish such statements with some sort of clause that physicians/providers may use as they see fit for the medical case. the point he is trying to make on this is discusssed in the article on radiology and the history of and process for regulating and bringing medical devices to market...per this article.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44706307

*****

and i sorta describe it here because i describe what i don't think the label will offer...

e.g., i don't see it being used for CT angiography...

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44118234

*****

now, for a more direct answer to your question...

anything re: mammo ~ would need to be applied/submitted for... i.e., no off-label use for that there...

anything re: weight-bearing CT scanning ~ would not be possible in current physical configurations as we know it... in other words, you will need to have a gantry which comes of from the floor for example to surround the region of interest, think hula hoop or something.

anything re: radiation therapy planning ~ this can be a possible off-label use in my opinion.

*****

in general, fluoroscopes do not provide the details of radiographic equipment... let me be more precise... radiologists would not want to go on record diagnosing a stress fracture of a finger/hand/wrist or of the say, 5th metatarsal of the foot based on a fluoro-image... good ole plain films will provide much better recorded detail. moreover, such fractures are sometimes occult fractures and will require nuclear medicine SPECT scanning to diagnose.

in general, fluoroscopes [more specific mobile fluoroscopes] are like any other viewing scope, i.e., think endoscopic surgery, or arthroscopic surgery, where the camera is put into the area. a fluoroscope can be used anywhere they want to see what they are doing... and how often do surgeons, interventionalists need to see what they are doing... answer: well, i wouldn't want one who keeps his eyes closed performing anything on me.

that said, for an example of an instance where no camera is necessary, as follows: to create a pocket to put in say an implantable generator (neuromodulator device, etc.) and then suture it in and close the site. however, i can't think of a situation where fluoro would not be necessary for the rest of these types of procedures. now, when speaking about electrophysiology cases, such as pacers, etc.... the fluoro-suite is most often some sort of fixed c-arm fluoro system. although, such departments typically have a one or two mobile systems on the floor (at least the ones i've been too).

but you get my point...

*****

thinking outloud, i think that the cone-beam CT feature of the DViS will have intra-operative uses/indications...as i mentioned in my "short-list of procedures" post.

if an ER wants to use it too, then in my opinion go right ahead...as long as the ER has the space/adequate footpring, i can't see any physical/logistical difficulties with that... consider the LODOX Statscan device i've mentioned before... the concept there is for trauma... in the ER setting... the Statscan is a radiography device... the point here is that the model for having some sorta radiation emitting device in an ER already exists. moreover...the Statscan is fixed unit. One ER system that i think of first when i think of the Statscan is the Shock Trauma system throughout Maryland and surrounding areas... then, think moble x-ray in the ER, that model exists obviously.

however, i believe there is a technology limit (at this time) to do brain CT scanning with existing cone-beam technology... this statement is based on my understanding of the literature...although i must preface that that literature i've read seems to have an affinity for the CereTom portable CT scanner...albeit that is a multidetector or multislice CT.