Replies to post #153334 on Vivos Inc (RDGL)

[Biggin 1]

Well, that’s encouraging we shall see soon I hope.

[rtg123]

TheraSphere was granted Humanitarian Device Exemption (HDE) in 1999: (https://www.accessdata.fda.gov/cdrh_docs/pdf/H980006A.pdf).

Effectiveness is not a requirement for HDE application: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption