This would probably involve convincing the Food and Drug Administration (FDA) that their policy makes no sense. I'm not sure how this can be done.
I can ask my Senators and local Representatives if they can somehow intervene - or maybe see if a local news station can take up the cause, but I'm not so sure of any level of success.
Also - getting approval for a new medical device, like the XS, may not be as daunting as it would seem to manufacturers (who should already know this). IIRC, Coagusense got FDA approval by demonstrating that results were close enough to those of an already approved device (the XS) to get approval.
There are at least two other devices sold in other countries that can probably go through (and pass) this process. I suspect that having three or four competing devices (I don't think that Coag-Sense has made much of a penetration - and I don't know if they are selling anywhere else in the world) might help to reduce prices of meters and strips (or, in one case, something called a 'chip').
Having a choice of approved meters - a significant choice of meters that ARE in use globally - might help competition and give us some choices. They may eventually make a small chip into the Roche 'machine' (I'm not talking about the XS here).
Currently, I'm aware of two other devices (iLine Microsystems microINR and QLabs' Q3 meter) that might be good candidates for considering FDA approval.
I can ask my Senators and local Representatives if they can somehow intervene - or maybe see if a local news station can take up the cause, but I'm not so sure of any level of success.
Also - getting approval for a new medical device, like the XS, may not be as daunting as it would seem to manufacturers (who should already know this). IIRC, Coagusense got FDA approval by demonstrating that results were close enough to those of an already approved device (the XS) to get approval.
There are at least two other devices sold in other countries that can probably go through (and pass) this process. I suspect that having three or four competing devices (I don't think that Coag-Sense has made much of a penetration - and I don't know if they are selling anywhere else in the world) might help to reduce prices of meters and strips (or, in one case, something called a 'chip').
Having a choice of approved meters - a significant choice of meters that ARE in use globally - might help competition and give us some choices. They may eventually make a small chip into the Roche 'machine' (I'm not talking about the XS here).
Currently, I'm aware of two other devices (iLine Microsystems microINR and QLabs' Q3 meter) that might be good candidates for considering FDA approval.