Well to throw a twist into the "8th" date. One must remember that they have 72 hours to report the information to the shareholders. I do not know if that means 72 hours from time of fax or three business days which would put it Monday the 12th sometime. Boy can you imagine how pissed some investors will be if they sell one day and approval comes in the next day. For me its SE or NSE. Period. No dates in the equation.
For the poster that stated 2d c arms were used for A-fib ablations yes. Hopefully a biplane system. The primary guiding system for the ablation catheter, in order to isolate the pulmonary veins would be something like StJudes ESI3000. Its a real time 3D mapping system using patches and impedance measurements to locate the catheters. I would think DVIS would be a better choice then biplane for the primary placement of the catheters. We will see one day soon I hope.
I wouldn't want to NOT have any shares at this stage. This x-ray device is praised as revolutionary within Radiology! If the FDA gives the nod for approval? This one goes thru the clouds!