A healthcare professional administered, sterile-packed, single-use medical device currently on the FDA 510(k) pathway for approval in the U.S. As a standalone medical device (not a combination product), the PLH offers the following features:
PLH can simplify the procedure for the user and may remove the variability associated with traditional techniques by having device geometry (and not the user) govern needle insertion depth.
PLH may be used immediately with any drug formulation and dose without requiring reformulation and complex in vitro assessment.
