regulatory
confidence high
sentiment neutral
materiality 0.65
LENSAR applies for CE Mark certification of ALLY System in European Union
LENSAR, Inc.
- Application for CE Mark certification of the ALLY Adaptive Cataract Treatment System submitted.
- CE Mark would allow commercialization of ALLY in the European Union following successful certification.
- Application follows U.S. FDA clearance of ALLY in June 2022 and the U.S. commercial launch.
- Company plans to use distributor network for EU commercialization, similar to first-generation system.