EU Medical Device Regulation (MDR) certification has been awarded to LENSAR Inc. for its ALLY Adaptive Cataract Treatment System.

LENSAR Inc.因其ALLY Adaptive白内障治疗系统获得了欧盟医疗器械法规（MDR）认证。

“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.

LENSAR总裁/首席执行官尼克·柯蒂斯（NickCurtis）表示：“我们很高兴获得ALLY的欧盟MDR认证，这对LENSAR来说是一个重要的里程碑。我们相信，ALLY在欧盟的商业可用性为我们创造了一个重要的增长机会，能够为欧洲外科医生提供新的功能和先进的下一代激光技术。”。

“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.”.

“欧洲白内障外科医生现在可以使用一种技术，该技术不仅可以提高手术的精确度，效率和患者满意度，还可以显着改善实践工作流程和经济性。”。

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.

获得MDR认证后，LENSAR可以为欧盟外科医生提供白内障手术的技术解决方案。据报道，ALLY是第一个使外科医生能够在单一无菌环境中无缝执行激光白内障手术的平台。由于其符合人体工程学的设计，增强的速度和功能，ALLY提高了患者和实践的效率。

The company is commercializing ALLY through its European Union distributor network and is currently placing ALLY Systems with surgeons on the continent..

该公司正在通过其欧盟经销商网络将ALLY商业化，目前正在欧洲大陆与外科医生一起部署ALLY系统。。

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

阅读更多：FDA批准LENSAR的ALLY Adaptive白内障治疗系统

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系统旨在解决老龄化第一代技术的性能局限性，同时使医生能够最大限度地提高手术室的效率，这得到了最近发表的时间和运动研究的支持。这些研究表明，节省了大量手术时间，从而增加了外科医生和门诊手术中心的收入机会，并减少了患者的吞吐量时间，从他们进入设施直到离开手术后。。

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.

ALLY的占地面积小，人体工程学增强，为外科医生提供了提高手术室或办公室手术室效率的机会。ALLY是第一个也是唯一一个在虹膜配准和散光管理表面识别中使用人工智能的白内障激光器，以及自动确定白内障密度，优化碎裂模式和能量设置，目标是最大限度地减少提供的总能量，以更有效地完成白内障手术，并有助于更快的视力恢复和更好的患者预后。

These proprietary features provide new opportunities for surgeons in laser cataract surgery procedures..

这些专有功能为外科医生在激光白内障手术程序中提供了新的机会。。

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.

LENSAR是一家商业舞台医疗器械公司，设计、开发和销售先进的白内障治疗和散光管理系统。LENSAR开发了其ALLY Adaptive白内障治疗系统，该系统是一种紧凑、高度符合人体工程学的系统，使用极快的双脉冲激光，并将AI集成到专有的成像和软件中。

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..

ALLY旨在利用LENSAR的先进技术改造优质白内障手术，该技术能够在无菌手术室或办公室手术室中执行整个手术，从而提高手术效率并减少开销。ALLY包括LENSAR专有的Streamline软件技术，该技术旨在指导外科医生取得更好的结果。。