Explaining Neuralink’s Human Trials Process

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.

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Edited by: Ryan Tanaka

#Neuralink #ElonMusk #HumanTrials

Видео Explaining Neuralink’s Human Trials Process канала Neura Pod – Neuralink