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To: reed13k

It’s not touching the patient. It’s really just a monitor. A very small monitor “mounted” on the surgeon. Which have been in operating rooms for years. And I doubt regular glasses go through the sterilization you outline either.


8 posted on 10/18/2024 8:32:16 AM PDT by discostu (like a dog being shown a card trick)
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To: discostu

It’s used in assisting treatment, doctor in the article even says as much, so it would be a device IF Apple claimed it as such per the regulations.

Mounted “monitors” are medical devices when used in operating rooms and claimed by the producer to be an assistance aid and/or ‘surgical room/clean room compatible’.

Been in the industry for 25 years working quality/regulatory issues. Don’t always agree with the regs, but if the company producing it claims it’s an aid in treatment it becomes a device.

In this case Apple doesn’t claim it...also why they refuse to claim any of the health benefits of the Apple Watch - despite it being better in many cases than other products out there claiming they are devices.


12 posted on 10/18/2024 9:16:53 AM PDT by reed13k
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