#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.  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