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?
Very interesting implantation method. I never would've thought it possible to use a stent like this. I think the most valuable IP produced from Synchron will be implementing ECoG without an extremely expensive (and risky!) craniotomy.
