Ellen: https://www.linkedin.com/in/ellenmaue/
00:00 Intro
01:02 Neuralink FDA application an IDE (Investigational Device Exemption?)
07:13 Full FDA trial timeline?
09:02 Does approval for one indication = approval for all?
10:20 Who selects trial participants?
11:48 Who is the principal investigator?
13:42 FDA equivalent in other countries?
16:00 General trial license possible?
17:46 Expedite timeline by paying more?
21:28 Neuralink trials special?
22:57 Trial process for drugs vs devices?
24:53 IDE, PMA, De Novo?
27:55 Class 1, 2, & 3 devices?
30:44 How often do research groups and companies work together?
34:09 Would merging with Synchron expedite the trials?
41:28 Comparing drug vs device patent life after approval
43:59 Neuralink's breakthrough device designation won't make approval faster
45:05 Additional context for Ellen's job
46:26 Thanks for watching. Please like/ subscribe.
Neura Pod is a series covering topics related to Neuralink, Inc. Topics such as brain-machine interfaces, brain injuries, and artificial intelligence will be explored. Host Ryan Tanaka synthesizes information, shares opinions, and conducts interviews to easily learn about Neuralink and its future.
Support: https://www.patreon.com/neurapod/
Please consider supporting by joining the channel above, or sharing my other company website with retirees: https://www.reterns.com/.
Opinions are my own. Neura Pod receives no compensation from Neuralink and has no affiliation to the company. Edited by: Ryan Tanaka
#Neuralink #ElonMusk #HumanTrials
Remember Everything You Learn from Podcasts
