Replies to post #5656 on Nutex Health Inc (NUTX)

[StockRoomBully]

Send proof link.

[MadeMan]

Exactly, this is how I understand it also.... This is bigger than just the wearable, because our data storage system "back end" can be linked with all wearables, watches, etc.

[Tool_power]

That is not how the FDA works. I have 22 yrs experience with FDA regulatory compliance. The FDA does not “Approve” a data center. They audit the data center to make sure that the infrastructure is validated and procedures are in place to ensure Data Integrity is maintained over the life of the data. You either Pass or Fail the audit.

Applications for approval are for devices that are either in or on the patient’s body (contact with the body). The Watch, Software application, and Data Center together constitute a ‘System’ that acquires, analyzes, reports, and stores regulated patient data.
The components are qualified (tested), then the system is holistically validated for its intended use. From there clinical testing can occur and the full package can be submitted for FDA approval, and can be audited at any time.

All that said, a validated, well-controlled data center provides a business asset that makes the overall package more valuable, but I would not say that the FDA Approval was specifically on the Data Center.

I like what I see here. Grabbed a starter position over the past few trading days. Would like some company communication before adding more though.