Lensar (Nasdaq:LNSR) announced today that it received FDA 510(k) clearance for its next-generation Ally system.
Orlando, Florida-based Lensar designed the Ally adaptive cataract treatment system to enable cataract surgeons to complete the femtosecond-laser-assisted cataract (FLACS) procedure seamlessly in a single, sterile environment.
According to a news release, the company intends to deliver the first Ally systems to surgeons in the third quarter of this year by way of a controlled and targeted initial launch, which will be followed by wide availability of the system to cataract surgeons in 2023.
Lensar said in the release that Ally has a small footprint with enhanced ergonomics, providing surgeons with a unique opportunity to improve efficiencies in any operating room or an in-office surgical suite. Ally represents the first cataract surgery platform to use adaptive intelligence to automatically determine cataract density, optimize fragmentation patterns and energy settings to minimize the overall energy delivered, allowing for the efficient completion of the procedure and quicker visual recovery with improved patient outcomes.
Ally’s proprietary features, combined with advanced astigmatism management technology, could establish new standards for femtosecond laser cataract surgery procedures, Lensar said.
“We are elated to bring this proprietary technology to cataract surgeons. Our mission has been to develop a platform where surgeons can seamlessly perform the entire FLACS procedure in a single setting, improve workflow efficiencies, and most importantly, help surgeons deliver better outcomes through the advanced technologies in the Ally System,” Lensar CEO Nick Curtis said. “We are seeing an overwhelmingly positive response to the Ally system. Over 125 surgeons have experienced Ally firsthand, during demonstrations performed at the American Society of Cataract and Refractive Surgery Annual Meeting in April, and more recently at our home office.”