The good thing for us is that artificial pancreases are regulated not as one device, but as three separate (interoperable) devices: the pumps, the sensors, and

The good thing for us is that artificial pancreases are regulated not as one device, but as three separate (interoperable) devices: the pumps, the sensors, and the control software. Only our control software is under a de-novo pathway ("totally new thing" pathway), everything else is 510k ("we know what this thing is" pathway). We also have Breakthrough Device designation, which really accelerates the regulatory timeline