Ann: Appointment of Sean Hehir as CEO, page-667

that was well over a year ago, and sound all excellent then, too. they had a working model, so what happened since?

many have mentioned FDA approval, and need for a control study.
This is a device and the pathway to approval is very different to approval.
Devices have better and quicker chance to approval than medication. particularly if non invasive and no safety concerns.
There have been lots of devices approved in a short time...also as i mentioned before a company took the FDA to court about a non approval for a device and won... since the FDA had to look at all those non approvals....
the FDA is a frickled lot and make inconsistant decison all the time... have approved drugs that don't work, and not safe...but big pharma has a says.
they actually contribute to the funding of the FDA....
let you all do the research... start with this one ...does big pharma fund the fda, and then look up that court case about 4 months ago, but it could have be yesterday with the way times passes for me.