Titan Medical Inc (TMDIF)

[RockoTaco]

Remember that Titan will need a US Sponsor to submit the IDE application.

Per FDA:

"Can a foreign company submit an IDE/Is a U.S. Sponsor required?

A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations."