Cogmedix , a US-based FDA compliant contract manufacturer helping medical device companies cost effectively improve their time-to-market, partnered with LensAR to manufacture a significant subassembly for the company’s refractive cataract surgery laser system.Designed to enhance the precision, predictability and safety of critical manual steps in cataract surgery, the LensAR Laser System™ brings lasers into the operating room to replace blades and greatly reduce the amount of ultrasound energy required to complete the removal of the natural crystalline lens in the majority of cataract removals.
Focused on fundamentally changing refractive cataract surgery procedures to an all-laser approach, LensAR selected Co gmedix based on the company’s cGMP compliant facility, PCB manufacturing capa bilities within Coghlin Companies, and its team of experts experienced in bringing new products to market on time and on budget – with total compliance adherence. As a subsidiary of Coghlin Companies, Cogmedix leverages 126 years of contract manufacturing history, experience and financial stability.
“The LensAR approach delivers laser capsulotomies, lens fragmentation, precise limbal relaxing incisions and unique clear corneal incisions with laser precision, all in a single procedure,” said Alan Connaughton, VP Operations at LensAR. “Partnering with Cogmedix on the motion platform subassembly translates to sustainable resource avoidance, freeing our team to focus on continued innovation, our US regulatory path, and final integration, calibration, and testing of the system.”
“LensAR’s system is an amazing combination of very sophisticated laser, optics, electronics, and software technologies . The foundation upon which these technologies are integrated is a complex base assembly with high precision machined components, a complex multi-axis motion platform, electronics, custom cables, and printed circuit boards. Cogmedix will build this highly integrated base subassembly in our ISO 13485 certified and FDA QSR compliant facility under the same compliance and process control as we would build a finished medical device. This helps enable the quality and traceability that LensAR desires in all aspects of their system.— said Matt Giza, General Manager, Cogmedix.
About LensAR, Inc.
LensAR, Inc. is a leader in the development and commercialization of a next generation laser and advanced 3D imaging technology for refractive cataract surgery. For more information please visit www.lensar.com.
The LensAR™ Laser System is cleared by the FDA for anterior capsulotomy and lens fragmentation. For other indications it is an investigational device limited by US law to investigational use only. The system has been used in more than 500 eyes outside the United States to date.
Cogmedix is a US-based, FDA QSR compliant, ISO 13485 certified contract manufacturer for medical and clinical devices. A subsidiary of Coghlin Companies Inc., Cogmedix focuses on the production of Class I and Class II medical and clinical devices for the critical care, home healthcare, emergency room, and industrial laboratories markets. Cogmedix focuses on aligning itself with companies seeking a compliant, conscientious, cost effective, domestic manufacturing resource to assist them with volume turnkey manufacturing. For more information about Cogmedix, please visit www.cogmedix.com.