#70 Explaining Neuralink's Human Trials

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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#Neuralink #ElonMusk #HumanTrials