Titan Medical Inc (TMDIF)

[66Mustang]

frequent1, thanks for that post. There are a couple good take-aways from it...

Trans-vaginal hyst is approved, clearing an easier pathway for Enos to get approved for it in the relatively near future. Always easier to be an "also-ran" with the FDA! Predicate devices are a big score!

And there's this:

"The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type."

A lot of questions raised here previously seemed to indicate there was worry about the de Novo pathway being a bad thing! Nope... on a preliminary basis, the FDA estimates Enos will qualify as de Novo and therefore is low to moderate risk, making for a much easier approval process from that aspect as well.

We're in great shape!


Message in reply to:
Congrats to others in the RASD space. The FDA granted marketing authorization of the Hominis Surgical System to Memic Innovative Surgery Ltd.

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-robotically-assisted-surgical-device-performing-transvaginal-hysterectomy

https://www.memicmed.com/