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June 14, 2022

Lensar secures FDA 510(k) clearance for Ally system

The Ally system provides adaptive intelligence to autonomously identify cataract density.

Medical technology firm Lensar has received 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation Ally Adaptive Cataract Treatment System.

Ally combines imaging and next-generation dual-pulse femtosecond laser in a single system.

It is said to be the first FDA-cleared platform to enable surgeons to perform a complete femtosecond-laser-assisted cataract surgery (FLACS) procedure in a single, sterile environment.

The system provides adaptive intelligence to autonomously identify cataract density, and optimise fragmentation patterns and energy settings.

When combined with astigmatism correction technology, the features of the Ally system have the potential to set new benchmarks for FLACS procedures.

The platform aims to reduce the overall energy needed to complete the cataract procedure efficiently, as well as contribute to faster visual recovery and improved patient outcomes.

Lensar stated that the small footprint and improved ergonomics of the Ally system offer surgeons the opportunity to enhance efficiencies in any operating room or in-office surgical suite.

Lensar CEO Nick Curtis said: “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.

“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.”

The company is planning a limited and targeted initial launch of the Ally system to surgeons in the third quarter of the year.

It will make the system more widely available to cataract surgeons next year.

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