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Re:NYC Brain Computer Startup Announces FDA Trial Before Elo... by elliekelly on Wednesday July 28, 2021 @10:14AM (#27983994)
I feel like maybe cybersecurity of implanted medical devices should be a basic requirement rather than a “we’ll get to that eventually” type of thing but it sounds like the FDA doesn’t agree. How can you reliably test the safety of a device if a critical component of the device’s safety is missing?

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