Titan Medical Inc (TMDIF)

[Geo2014]

PMA is not the chosen route for any company. And the filing verbiage may not be a big deal... but what if it is?

Here is a good reference on the process...

https://www.emergobyul.com/resources/usa-process-chart

Per this reference:

Devices with a new intended use or novel technology are automatically placed into Class III by the FDA. A novel device that is shown not to be high risk may be reviewed and placed on the market as a Class I or II under a De Novo Classification submission.


Titan makes mention of the De Novo submission in the filing. Perhaps the statement in the filing is referring to a "novel technology?" I agree with Belize that da Vinci SP should / will be considered the predicate device. But Magnus brings up a good question... are they covering their asses in case it is not?

The other factor is the FDA coming down on RAS devices being used for "off-label" cancer removal. Could they be reconsidering a reclassification from II to III for new devices?