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This is a great point, and precisely why we're using two sensors and a simple voting algorithm in our first in man trial (3+ sensors and associated algorithms w
by idealmedtech 5y ago
This is a great point, and precisely why we're using two sensors and a simple voting algorithm in our first in man trial (3+ sensors and associated algorithms were deemed too risky by FDA for initial studies).
- kudosycnews 5y agoNot sure what sensors you are using... why FDA thinks more sensors carry higher risk?
- idealmedtech 5y agoIt's not the number of sensors, it's the novelty of the voting algorithm required to fuse those sensors that gives them pause. FDA likes to be _VERY_ conservative when it comes to trying new things. We're trialing our control software, which is already novel to them, so anything we can do that's not brand new helps reduce our risk.
- kudosycnews 5y agoMore information should help make more informed devision, if the algorithm can not clearly explain it to FDA or FDA cannot understand that is the case... something seems wrong here... all the best wishes and also encourage more exploration.