Yeah I posted about this a while back, basically the XV Technology is classified as low to medium risk to the patient, this means that the FDA will only ever need to "clear" the XV Technology, there is no need for approval. Technologies, devices or drugs that are new or high risk have to go though greater scrutiny and need to obtain FDA Approval before they can go to market with the product. 4DX's XV Technology only required "clearance" in order to be allowed to go to market. They got clearance earlier this year.
More detail here
https://www.theralight.com/the-difference-between-fda-registered-fda-approved-and-fda-cleared/
Yeah I posted about this a while back, basically the XV...
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