EU Medical Device Regulation (MDR) certification has been awarded to LENSAR Inc. for its ALLY Adaptive Cataract Treatment System.
 
“We are thrilled to receive EU MDR certification for ALLY, which marks a significant milestone for LENSAR. We believe ALLY’s commercial availability in the EU creates a significant growth opportunity for us, through the ability to provide new capabilities and advanced next-generation laser technology to European surgeons,” LENSAR President/CEO Nick Curtis said. “European cataract surgeons now have access to a technology that has demonstrated to not only enhance the precision, efficiency and patient satisfaction associated with the procedure, but also to significantly improve practice workflow and economics.”
 
Receiving MDR certification allows LENSAR to provide EU surgeons with a technology solution for cataract procedures. ALLY is reportedly the first platform that enables surgeons to perform a laser cataract procedure seamlessly in a single, sterile environment. Due to its ergonomic design, enhanced speed and features, ALLY increases both patient and practice efficiencies. The company is commercializing ALLY through its European Union distributor network and is currently placing ALLY Systems with surgeons on the continent.

---

READ MORE: FDA Clears LENSAR’s ALLY Adaptive Cataract Treatment System

---

 
The ALLY System is designed to address the performance limitations of aging, first-generation technologies while simultaneously enabling physicians to maximize efficiency in the operating room, as supported by recently published time and motion studies. These studies have shown significant procedure time savings resulting in increased revenue opportunities for both surgeons and ambulatory surgery centers, as well as less throughput time for patients, beginning with the time they enter the facility until they leave post-procedure.
 
ALLY’s small footprint and enhanced ergonomics provide surgeons an opportunity to improve efficiencies in any operating room or in-office surgical suite. ALLY is the first and only cataract laser to use artificial intelligence in the iris registration and surface identification of astigmatism management, as well as to automatically determine cataract density, optimize fragmentation patterns, and energy settings, with the goal of minimizing the overall energy delivered to complete the cataract procedure more efficiently and help contribute to quicker visual recovery and better patient outcomes. These proprietary features provide new opportunities for surgeons in laser cataract surgery procedures.
 
LENSAR is a commercial-stage medical device company that designs, develops, and markets advanced systems for cataract treatment and astigmatism management. LENSAR developed its ALLY Adaptive Cataract Treatment System as a compact, highly ergonomic system using an extremely fast dual-pulse laser and integrating AI into proprietary imaging and software. ALLY is designed to transform premium cataract surgery by utilizing LENSAR’s advanced technologies with the ability to perform the entire procedure in a sterile operating room or in-office surgical suite, delivering operational efficiencies and reducing overhead. ALLY includes LENSAR’s proprietary Streamline software technology, which is designed to guide surgeons to achieve better outcomes.