Lensar Announces Application for Certification of the ALLY Adaptive Cataract Treatment System in the EU

Lensar announced the application for certification of the ALLY Adaptive Cataract Treatment System in the European Union.

“Following the FDA clearance of ALLY in June 2022 and recent US commercial launch, this is another important step in our effort to bring ALLY to cataract surgeons in key global markets. Our mission has always been to create a platform that optimizes the way premium cataract surgeries are performed, and we believe that ALLY addresses all limitations of current competitive technologies,” Nick Curtis, Chief Executive Officer of Lensar, said in a company news release. “Following successful completion of the certification process, we are prepared to launch ALLY in the EU. This application marks yet another major milestone met for Lensar in 2022.”

ALLY is designed to enable surgeons to complete a femtosecond-laser-assisted cataract surgery (FLACS) procedure seamlessly in a single, sterile environment and provide Adaptive Intelligence to automatically determine cataract density, optimize fragmentation patterns, and energy settings. The CE Mark, if affixed following successful completion of the certification process, allows for commercialization of ALLY in the European Union. The application for certification in the European Union follows FDA clearance of ALLY in June 2022. If ALLY is certified and CE marked, Lensar plans to make the system commercially available to European surgeons through a distributor network, similar to the approach taken for its first-generation Lensar Laser System.