Takeoff41's TPN2.0 completes FDA review

The FDA determined that TPN2.0 does not meet the definition of a regulated medical device, because the system provides recommendations that clinicians can always review, adjust, or override before any prescription is finalized.

The determination confirms the design principle at the core of TPN2.0: the final order is always the clinician's, with the software doing the arithmetic and the safety checks behind it.