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This... brought back some memory...to average or not to average... C8 Medisensors achieved better weekly MARD in the early 201*. But the problem was, on a bad d
by kudosycnews 5y ago
This... brought back some memory...to average or not to average... C8 Medisensors achieved better weekly MARD in the early 201*. But the problem was, on a bad day, no one knows why it was bad..., so no way to alert the user (unless the reading was way off). Even though on "average", performance looks nice, but a bad day the data can be very problematic for a user, and the user has not way to trust the device based on MARD...
- idealmedtech 5y agoThis 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.