in2being is hiring software and med device engineers!
[ Ссылка ]
#multiplesclerosis #sterilization #fda #medtech #medtechvlog
/ How New Sterilization Methods Get Recognized by FDA
We interview Tony Eisenhut, CEO of NovaSterilis who will describe how new sterilization methods are accepted by FDA, what's out there, and NovaSterilis' novel supercritical sterilization method!
/ FDA Approves New Biosimilar for Multiple Sclerosis
There's new hope for those suffering from MS, and it's not a drug... it's a biologic, or more specifically, a biosimilar. Today we'll learn all about biosimilars and what FDA just approved.
Chapters
0:00 - Gene can now feel pumpkin spice
1:12 - New biologic treatment for multiple sclerosis
9:07 - Sterilization discussion with Tony Eisenhut, CEO of NovaSterilis
11:15 - How do people sterilize things?
15:22 - Small businesses and ethylene oxide
13:58 - Why is everyone so eager to get new methods of sterilization?
17:45 - What are the categories that FDA has established for sterilization?
22:58 - Not everything medical has to be sterilized
24:50 - 10 to the minus 6th?
26:08 - The starting load of sterilization
30:26 - FDA's new standard for sterilization
34:35 - NovaSterilis and the FDA
39:53 - How does NovaSterilis compare to ETO?
42:40 - What NovaSterilis sterilzes
45:18 - Who can use NovaSterilis?
49:23 - Local and National Events
52:57 - Outro
Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET!
MTC Playlist on YouTube: [ Ссылка ]
MTC Playlist on Spotify: [ Ссылка ]
MTC Playlist on Apple Podcasts: [ Ссылка ]
MTC Playlist on Google Podcasts: [ Ссылка ]
in2being: [ Ссылка ]
MTC Landing Page: [ Ссылка ]
MTC How Do I Get a 510(k) Series Playlist: [ Ссылка ]
MTC De-Risking Medical Device Development Series Playlist: [ Ссылка ]
Segment Links:
[ Ссылка ]
[ Ссылка ]
[ Ссылка ]
Events:
[ Ссылка ]
[ Ссылка ]
[ Ссылка ]
[ Ссылка ]
[ Ссылка ]
[ Ссылка ]
CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE
155 - New Multiple Sclerosis Treatment Approved by FDA
Теги
new fda approved multiple sclerosisfda approved multiple sclerosis treatmentnew fda approved multiple sclerosis biological treatmentnew sterilization methodsnew fda sterilization methods recognizedtony eisenhutfdamedtechfda master filefda sterilization methodsfda sterilizationnovel fda sterilizationfda novel sterilization processsterilizationmedtech sterilizationnovasterilisfda sterilization recognitiontyrukotysabrimultiple sclerosisms treatment