LENSAR, Inc., a global medical technology company focused on advanced femtosecond laser surgical solutions for the treatment of cataracts, has announced the application for certification of the ALLY™ Adaptive Cataract Treatment System (“ALLY” or the “ALLY System”) in the European Union.
“Following the FDA clearance of ALLY in June 2022 and recent U.S. 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.” said Nick Curtis, Chief Executive Officer of LENSAR. “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 enables 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 U.S. 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.
Source: lensar.com