Takeoff41's TPN2.0 completes FDA review

Takeoff41's AI-driven TPN tool completed FDA review in January 2026. 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.

This determination clears the regulatory path for deployment in hospital NICUs without the need for device clearance. TPN2.0 integrates directly with existing EHR systems, including Epic.