Titan Medical Inc (TMDIF)

[Times Yours]

Good find. Thanks for sharing. Definitely something to dive into. I want to say that 510 k clearance involves using a predicate device(as an example ISRG SP robot) along with verification and validation to show safety with porcine and cadaver labs. Some time ago Titan seemingly dropped pursuing a predicate device submission and started pursuing IDE and completion of human trials. Could this be related? It seemed overkill at the time but perhaps it was in relation to this. If so, we may be way ahead of the game. I’d love to hear from someone with experience in this area.