Titan Medical Inc (TMDIF)

[RockoTaco]

For all those who are interested in educating themselves on fda breakthrough designation

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

Like I said Titan is way ahead of where these companies are and has clear guidance from fda and has been in constant communication w them.


This is my favorite part in the fda words of course

What are the benefits of the Breakthrough Devices Program?
The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.


Offers a company a chance to interact w FDA!

Titan is way past this part and has clear guidance from fda and has been in constant communication w them