regulatory
confidence high
sentiment neutral
materiality 0.50
RxSight receives FDA request for additional info on lower-cost LDD; expects no timeline impact
RxSight, Inc.
- FDA requested additional information for approval of lower-cost-to-manufacture Light Delivery Device (LDD).
- Commercial sale of the lower-cost LDD not planned until 2023; company believes it can meet the timeline.
- Lower-cost LDD has the same functionality as the currently marketed LDD.