Replies to post #18066 on Titan Medical Inc (TMDIF)

[Bristol19]

I see where you are coming from in that the FDA would not promote more indications to Titan as a way to encourage exercising any market advantage.

However, there are preliminary and informal discussions available with the FDA where they actively promote investigational and technical development that they think can improve the medical device as they envision it helping the public good. In other words, they might agree with you it is a good idea, and suggest the proper pathways/pitfalls in pursuing future approvals. That is part of their model now to promote device development and make the approval process less stifling. (although King Obama would have that taxed)

I have been to those type meetings with FDA. They are informal but begin to break the ice, make personal introductions, get ideas across, etc.. Companies are wise to try to arrange them and usually they would involve the science, medical, and engineering personnel, rether than CEOs and business or investment staff.

[Honeycomb777]

3 different long-time posters have said that the FDA suggested it (most likely through feedback via the Ximedica teams closest to the FDA)