https://www.businesswire.com/news/home/20231107892415/en/Recor-Medical-and-Otsuka-Medical-Devices-Announce-First-FDA-Approved-Renal-Denervation-System-for-the-Treatment-of-Hypertension
14 years and $5B later, we are still waiting while an unknown startup was able to secure the first approval
This didn’t age well…
https://news.medtronic.com/fda-approves-medtronic-symplicity-spyral-renal-denervation-system-for-high-blood-pressure-newsroom#:~:text=The%20U.S.%20Food%20and%20Drug,and%20help%20lower%20blood%20pressure.
I mean they failed on data though, not the technology. Claiming it's the same thing would still not let them bypass the data.
This is not a 510K it's a PMA application. Totally different criteria
Medtronic will likely now point at their therapy and state theirs does something similiar, sort of, kind of, maybe ....
Medtronic Mindset wins again!!
Congrats Geoff and Karen you f*cking hacks
Thank the board!
Medtronic will have to run another study.
They may wait a year and see what Recor sales look like - there's a huge question if the blood pressure decrease is worth it even for Recor.
I don’t expect FDA to approve the response the project team is sending. After watching parts of the panel recording, it was obvious that there were a lot of flaws in the study design. How do you reanalyze the existing data to make FDA happy?